Drug law & regulations
•Download as PPT, PDF•
4 likes•1,366 views
This document outlines the development of drug regulations in the United States by various agencies over time, including the 1906 Pure Food and Drug Act, the 1970 Controlled Substances Act, and more recent laws. It also summarizes security features required on prescriptions, drug recall classifications, labeling requirements for prescription versus over-the-counter drugs, and the role of the California State Board of Pharmacy in licensing and oversight.
Report
Share
Report
Share
Recommended
Drug Regulatory Affairs By Mr. Pankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
Role of ADR monitoring centre
The document outlines the evolution of India's pharmacovigilance program over time from 1986 to present. It began with proposals for regional adverse drug reaction (ADR) monitoring centers and eventually became the National Pharmacovigilance Program (PvPI) in 2004 with multiple zonal, regional, and peripheral centers. PvPI is administered by steering and advisory committees and collects ADR reports through over 250 ADR Monitoring Centers to analyze patterns and make regulatory recommendations. The role of monitoring centers is to collect, process, and report ADR data using the Vigiflow software system.
Regulatory affairs
Introduction, Historical overview of regulatory affairs, Regulatory authorities, Role of regulatory affair department, Responsibility
Cdsco ppt
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
REGULATORY AFFAIR
This document provides an overview of regulatory affairs and the new drug development process. It defines regulatory affairs as a profession focused on collecting, analyzing, and communicating risk-benefit information of healthcare products to regulatory agencies. The new drug development process involves discovery, pre-clinical studies, investigational new drug application, clinical trials, new drug application, and post-marketing activities. Key goals of regulatory affairs include protecting human health, ensuring safety and efficacy, and providing accurate product information.
Common Technical Document
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It describes the evolution and adoption of the CTD internationally and in India. The CTD aims to streamline the drug approval process and facilitate simultaneous reviews by different regulators. It is organized into five modules covering administrative information, summaries, quality, nonclinical data, and clinical data. Widespread use of the CTD format has allowed for greater harmonization and efficiency in global pharmaceutical development and regulation.
Pharmacovigilance
Pharmacovigilance is the science of monitoring the effects of medicines after they have been licensed for use, in order to identify new safety hazards and assess risks and benefits. It aims to improve patient care and safety in relation to medicine use. The thalidomide disaster in the 1960s demonstrated the need for formal pharmacovigilance systems to detect adverse drug reactions. Spontaneous reporting by healthcare professionals and mandatory reporting by manufacturers are key methods for collecting information on adverse drug events. Reports are assessed for causality and contribute to the ongoing evaluation of medicines to ensure their safe and effective use.
CDSCO- Functions & Responsibilities
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
Recommended
Drug Regulatory Affairs By Mr. Pankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
Role of ADR monitoring centre
The document outlines the evolution of India's pharmacovigilance program over time from 1986 to present. It began with proposals for regional adverse drug reaction (ADR) monitoring centers and eventually became the National Pharmacovigilance Program (PvPI) in 2004 with multiple zonal, regional, and peripheral centers. PvPI is administered by steering and advisory committees and collects ADR reports through over 250 ADR Monitoring Centers to analyze patterns and make regulatory recommendations. The role of monitoring centers is to collect, process, and report ADR data using the Vigiflow software system.
Regulatory affairs
Introduction, Historical overview of regulatory affairs, Regulatory authorities, Role of regulatory affair department, Responsibility
Cdsco ppt
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
REGULATORY AFFAIR
This document provides an overview of regulatory affairs and the new drug development process. It defines regulatory affairs as a profession focused on collecting, analyzing, and communicating risk-benefit information of healthcare products to regulatory agencies. The new drug development process involves discovery, pre-clinical studies, investigational new drug application, clinical trials, new drug application, and post-marketing activities. Key goals of regulatory affairs include protecting human health, ensuring safety and efficacy, and providing accurate product information.
Common Technical Document
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It describes the evolution and adoption of the CTD internationally and in India. The CTD aims to streamline the drug approval process and facilitate simultaneous reviews by different regulators. It is organized into five modules covering administrative information, summaries, quality, nonclinical data, and clinical data. Widespread use of the CTD format has allowed for greater harmonization and efficiency in global pharmaceutical development and regulation.
Pharmacovigilance
Pharmacovigilance is the science of monitoring the effects of medicines after they have been licensed for use, in order to identify new safety hazards and assess risks and benefits. It aims to improve patient care and safety in relation to medicine use. The thalidomide disaster in the 1960s demonstrated the need for formal pharmacovigilance systems to detect adverse drug reactions. Spontaneous reporting by healthcare professionals and mandatory reporting by manufacturers are key methods for collecting information on adverse drug events. Reports are assessed for causality and contribute to the ongoing evaluation of medicines to ensure their safe and effective use.
CDSCO- Functions & Responsibilities
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
Federal food, drug & cosmetics act
The document discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Kefauver-Harris Amendments of 1962. The FFDCA was passed in 1938 in response to tragedies from unsafe drugs and gave more authority to the FDA. The Kefauver-Harris Amendments of 1962 required drug manufacturers to prove a drug's efficacy and safety before approval in response to the thalidomide crisis. The amendments strengthened pre-market drug approval processes and mandated new drug efficacy studies.
regulatory approval process of drug, cosmetic and herbals in canada
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
Case Report Form (CRF)
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Drug regulatory authority
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
Declaration of helsinki (Pharmacology SEM-III)
The document presents information on the Declaration of Helsinki (DoH), including its history, development, scope, and basic ethical principles for medical research involving human subjects. It notes that the DoH is a cornerstone document developed by the World Medical Association that has undergone several revisions since 1964 to update principles for ethical human research. The summary provides an overview of the key topics covered in the document.
GOOD REGULATORY PRACTICE.pptx
This document discusses good regulatory practices in the pharmacy industry. It defines good regulatory practices as internationally recognized processes, systems, tools, and methods for improving the quality of regulation. It describes different types of pharmacies, including community pharmacies which serve society's drug needs, and retail and wholesale pharmacies which purchase and distribute medicines. It notes that good regulatory practices in community and wholesale pharmacies include submitting license applications online, verifying documents, paying fees electronically, and maintaining electronic records for easy traceability.
CENTRAL TESTING LABORATORIES IN INDIA
The document discusses drug regulations and central testing laboratories in India. It provides information on the Central Drugs Standard Control Organization (CDSCO), which is responsible for regulating drugs in India. It oversees several laboratories across India that test drugs. The document also discusses ethics committees, new drug approvals, and the benefits of accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
generic drugs
The document discusses generic drugs, including their regulatory approval process. Generic drugs must demonstrate bioequivalence to the branded version to gain approval. They are approved through an abbreviated new drug application that shows they deliver the same amount of active ingredients as the branded drug. India has a large and growing generic drug industry that supplies over 30% of the global generic market. Recent FDA rules now require generic drug makers to pay user fees for product approvals.
Essential Documents For the Conduct of Clinical Trial
This document outlines essential documents that should be generated and maintained before, during, and after a clinical trial. It lists key documents such as the investigator brochure, signed protocol and consent forms, financial agreements, IRB approval, investigator qualifications, safety reporting procedures, and monitoring visit reports. Maintaining these documents allows evaluation of trial conduct and data quality. The documents are to be located in both investigator and sponsor files, with some only requiring location in one file. Proper documentation helps ensure compliance with regulations and good clinical practice standards.
Schedule Y
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Clinical trials
Clinical trials involve testing investigational drugs or treatments on human subjects to determine safety and efficacy. They progress through several phases, beginning with small pre-clinical trials on animals. Phase 1 trials involve 20-50 healthy volunteers to assess pharmacokinetics and safety. Phase 2 trials enroll 50-300 patient volunteers to further evaluate safety and dosage. Phase 3 trials are large randomized controlled trials of 250-1000+ subjects comparing the investigational treatment to standard treatment or placebo. If Phase 3 is successful, the results are submitted to regulatory agencies for approval to market the new drug. Post-marketing Phase 4 trials monitor long-term safety and efficacy.
New drug development
Development of new drug starting from drug discovery to clinical trials. Includes stages of preclinical studies and phases of clinical trial.
Schedule Y
Schedule Y amended version 2005,
I hope this is useful to All Clinical Research Professionals.
-Thank You
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptx
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Central drug standard control organisation
The CDSCO is the main regulatory body for pharmaceuticals, medical devices, and clinical trials in India. It is headquartered in New Delhi and functions under the Ministry of Health and Family Welfare. The DCGI is responsible for approving new drugs, medical devices, and clinical trials in India and is advised by technical committees. The CDSCO has zonal, sub-zonal, and port offices that perform regulatory functions like GMP audits and drug testing. State drug control organizations also regulate drugs and enforce drug standards at the local level.
Generic drug
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
ba be studies
This document discusses bioavailability and bioequivalence studies. It begins by introducing the importance of ensuring uniform quality, efficacy, and safety of pharmaceutical products marketed by different companies. It describes how bioavailability measures the rate and extent that a drug reaches systemic circulation, while bioequivalence ensures drugs from different sources have similar rates and extents of absorption. The document then discusses factors that can affect bioavailability like dosage form, physiology, and disease states. It also defines pharmaceutical equivalents and alternatives in establishing bioequivalence. Finally, it provides an overview of the different study designs used in pharmacokinetic studies to assess bioequivalence.
METHODS OF POST MARKETING SURVEILLANCE
Post-marketing surveillance (PMS) monitors drug and medical device safety after market release using approaches like spontaneous reporting databases, prescription monitoring, and health records. PMS identifies potential safety issues through data review and helps detect rare or long-term adverse effects not seen in pre-market clinical trials which have limited patient populations and durations. PMS provides additional safety and efficacy information on marketed products and allows monitoring of special patient groups. Common PMS methods include spontaneous reporting, observational studies, randomized trials, and active surveillance networks.
Clinical Research, A Basic Understanding...........
The slide provides a basic understanding about Clinical Research process and the various Phases of Drug Discovery and Development. It also explains about the various trial designs and techniques in research such as blinding and randomization. It may be useful for giving a basic class for Fourth Year B.Pharm Students.
Canberra Drug Law Reform Apgdlr 2006
The document discusses the current status and future prospects of drug law reform. It summarizes that the global drug situation continues to worsen, with more countries, drug quantities, and adverse consequences. There is growing support for harm reduction policies and programs over prohibitionist approaches. However, progress requires pragmatic approaches that are both economically and politically sustainable, through compromise instead of attempting to eradicate drug use entirely. Reform will likely be a slow evolution rather than a rapid revolution.
Interprofessional communication (3)
This document describes using streaming media to teach interprofessional communication skills to nursing students. It presents three clinical scenarios recorded with human simulators to engage students in asynchronous learning. Students use the SBAR method to organize information from each scenario. Their use of SBAR to communicate clinical information will be evaluated through high-fidelity simulation and a student feedback form will collect perceptions of the streaming media exercise.
More Related Content
What's hot
Federal food, drug & cosmetics act
The document discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Kefauver-Harris Amendments of 1962. The FFDCA was passed in 1938 in response to tragedies from unsafe drugs and gave more authority to the FDA. The Kefauver-Harris Amendments of 1962 required drug manufacturers to prove a drug's efficacy and safety before approval in response to the thalidomide crisis. The amendments strengthened pre-market drug approval processes and mandated new drug efficacy studies.
regulatory approval process of drug, cosmetic and herbals in canada
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
Case Report Form (CRF)
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
Drug regulatory authority
The document summarizes the drug regulatory system in India. The key points are:
- The Central Drugs Standard Control Organization (CDSCO) regulates pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
- CDSCO's functions include ensuring drug safety, efficacy and quality; approving new drugs and clinical trials.
- The Drugs Controller General of India heads CDSCO and is advised by the Drug Technical Advisory Board and Drugs Consultative Committee.
- State drug control administrations enforce drug regulation at the state level under the central Drugs and Cosmetics Act.
Declaration of helsinki (Pharmacology SEM-III)
The document presents information on the Declaration of Helsinki (DoH), including its history, development, scope, and basic ethical principles for medical research involving human subjects. It notes that the DoH is a cornerstone document developed by the World Medical Association that has undergone several revisions since 1964 to update principles for ethical human research. The summary provides an overview of the key topics covered in the document.
GOOD REGULATORY PRACTICE.pptx
This document discusses good regulatory practices in the pharmacy industry. It defines good regulatory practices as internationally recognized processes, systems, tools, and methods for improving the quality of regulation. It describes different types of pharmacies, including community pharmacies which serve society's drug needs, and retail and wholesale pharmacies which purchase and distribute medicines. It notes that good regulatory practices in community and wholesale pharmacies include submitting license applications online, verifying documents, paying fees electronically, and maintaining electronic records for easy traceability.
CENTRAL TESTING LABORATORIES IN INDIA
The document discusses drug regulations and central testing laboratories in India. It provides information on the Central Drugs Standard Control Organization (CDSCO), which is responsible for regulating drugs in India. It oversees several laboratories across India that test drugs. The document also discusses ethics committees, new drug approvals, and the benefits of accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
generic drugs
The document discusses generic drugs, including their regulatory approval process. Generic drugs must demonstrate bioequivalence to the branded version to gain approval. They are approved through an abbreviated new drug application that shows they deliver the same amount of active ingredients as the branded drug. India has a large and growing generic drug industry that supplies over 30% of the global generic market. Recent FDA rules now require generic drug makers to pay user fees for product approvals.
Essential Documents For the Conduct of Clinical Trial
This document outlines essential documents that should be generated and maintained before, during, and after a clinical trial. It lists key documents such as the investigator brochure, signed protocol and consent forms, financial agreements, IRB approval, investigator qualifications, safety reporting procedures, and monitoring visit reports. Maintaining these documents allows evaluation of trial conduct and data quality. The documents are to be located in both investigator and sponsor files, with some only requiring location in one file. Proper documentation helps ensure compliance with regulations and good clinical practice standards.
Schedule Y
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Clinical trials
Clinical trials involve testing investigational drugs or treatments on human subjects to determine safety and efficacy. They progress through several phases, beginning with small pre-clinical trials on animals. Phase 1 trials involve 20-50 healthy volunteers to assess pharmacokinetics and safety. Phase 2 trials enroll 50-300 patient volunteers to further evaluate safety and dosage. Phase 3 trials are large randomized controlled trials of 250-1000+ subjects comparing the investigational treatment to standard treatment or placebo. If Phase 3 is successful, the results are submitted to regulatory agencies for approval to market the new drug. Post-marketing Phase 4 trials monitor long-term safety and efficacy.
New drug development
Development of new drug starting from drug discovery to clinical trials. Includes stages of preclinical studies and phases of clinical trial.
Schedule Y
Schedule Y amended version 2005,
I hope this is useful to All Clinical Research Professionals.
-Thank You
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptx
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Central drug standard control organisation
The CDSCO is the main regulatory body for pharmaceuticals, medical devices, and clinical trials in India. It is headquartered in New Delhi and functions under the Ministry of Health and Family Welfare. The DCGI is responsible for approving new drugs, medical devices, and clinical trials in India and is advised by technical committees. The CDSCO has zonal, sub-zonal, and port offices that perform regulatory functions like GMP audits and drug testing. State drug control organizations also regulate drugs and enforce drug standards at the local level.
Generic drug
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
ba be studies
This document discusses bioavailability and bioequivalence studies. It begins by introducing the importance of ensuring uniform quality, efficacy, and safety of pharmaceutical products marketed by different companies. It describes how bioavailability measures the rate and extent that a drug reaches systemic circulation, while bioequivalence ensures drugs from different sources have similar rates and extents of absorption. The document then discusses factors that can affect bioavailability like dosage form, physiology, and disease states. It also defines pharmaceutical equivalents and alternatives in establishing bioequivalence. Finally, it provides an overview of the different study designs used in pharmacokinetic studies to assess bioequivalence.
METHODS OF POST MARKETING SURVEILLANCE
Post-marketing surveillance (PMS) monitors drug and medical device safety after market release using approaches like spontaneous reporting databases, prescription monitoring, and health records. PMS identifies potential safety issues through data review and helps detect rare or long-term adverse effects not seen in pre-market clinical trials which have limited patient populations and durations. PMS provides additional safety and efficacy information on marketed products and allows monitoring of special patient groups. Common PMS methods include spontaneous reporting, observational studies, randomized trials, and active surveillance networks.
Clinical Research, A Basic Understanding...........
The slide provides a basic understanding about Clinical Research process and the various Phases of Drug Discovery and Development. It also explains about the various trial designs and techniques in research such as blinding and randomization. It may be useful for giving a basic class for Fourth Year B.Pharm Students.
What's hot (20)
regulatory approval process of drug, cosmetic and herbals in canada
regulatory approval process of drug, cosmetic and herbals in canada
Essential Documents For the Conduct of Clinical Trial
Essential Documents For the Conduct of Clinical Trial
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptx
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptx
Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........
Viewers also liked
Canberra Drug Law Reform Apgdlr 2006
The document discusses the current status and future prospects of drug law reform. It summarizes that the global drug situation continues to worsen, with more countries, drug quantities, and adverse consequences. There is growing support for harm reduction policies and programs over prohibitionist approaches. However, progress requires pragmatic approaches that are both economically and politically sustainable, through compromise instead of attempting to eradicate drug use entirely. Reform will likely be a slow evolution rather than a rapid revolution.
Interprofessional communication (3)
This document describes using streaming media to teach interprofessional communication skills to nursing students. It presents three clinical scenarios recorded with human simulators to engage students in asynchronous learning. Students use the SBAR method to organize information from each scenario. Their use of SBAR to communicate clinical information will be evaluated through high-fidelity simulation and a student feedback form will collect perceptions of the streaming media exercise.
Cattigan- Doing it for the Kids
This document discusses caring for pediatric patients in an adult ICU in Geelong, Victoria. It notes barriers to caring for pediatric patients and differences compared to adult patients. It outlines the adult ICU team's skills and collaboration needed with pediatrics. Equipment, monitoring, medications, and resources required are reviewed. Education for nursing on a 3 stage program and courses like APLS are mentioned. Outcomes have improved since establishing a pediatric ICU liaison service for transfers and telehealth support. The goal is for most pediatric patients to be managed locally in Geelong rather than transferring to Melbourne.
Communicate To Connect - The New Rules of Communication
Based on one of Pam's blogs; the Bog Standard New Rules of Communication. Find 10 tips to improve the way you connect with people through your communication style. Great for the boss or anyone who wants to break through the clutter and better connect with people.
Interprofessional Communication: Challenges and Opportunities - Walter Eppich
This document discusses interprofessional communication challenges and opportunities. It notes that competent individuals may form incompetent teams, and that communication breakdowns can impair learning and team performance. It emphasizes that a supportive workplace culture with psychological safety is key. When people feel safe speaking up about concerns, mistakes, or asking questions, teams can achieve collective competence through open communication and learning conversations. Specific aids like checklists and frameworks can help facilitate productive discussions. Leaders play an important role in establishing a culture where input is welcomed and people are empowered to solve problems together.
Neonatal Intensive Care: Trish Woods
Trish Woods guides you through some clinical pearls in the intensive care management of neonates.
The complex physiology of the transitioning required in the journey from foetal life to neonatal presents many challenges and scary moments.
Trish helps you to navigate these challenges and to unlock the key to providing quality neonatal intensive care.
Many things can go wrong in the neonatal period as babies transition to life in the real world. Trish highlights her thoughts on the use of positive end expiratory pressure (PEEP), how deep to intubate, when to clamp the cord and the use of ultrasound.
When babies arrive early their lungs can be full of meconium or fluid. Due to this, Trish recommends using PEEP – without which there is distal airway collapse and fluid accumulation.
Aeration of the lungs is vital. To this end, how deep should intubation be aimed? The depth may not be overly important. This is because regional lung aeration triggers widespread, global increase in pulmonary blood flow.
There is little definitive evidence to guide clinicians on when to clamp the cord – early or late. Trish recommends considering the physiology of clamping the cord.
After clamping the cord there is a massive drop in cardiac output. Ventilatory support will turn this around – something to remember.
In a compromised baby, perhaps we should aim to clamp the cord sooner and then initiate ventilation.
Finally, Trish highlights the utility of ultrasound. Viewing the heart and lungs provides crucial information for the clinician.
Furthermore, Trish discusses actively looking for aeration, collapse, consolidation and pneumothorax in the lungs and thorax.
Overall, don’t forget the essentials. Trish reminds you to keep life sweet, warm, and tempting and help neonates to transition into the big world.
Neonatal Intensive Care: Trish Woods
For more like this, head to our podcast page. #CodaPodcast
Teamwork: The strongest drug in the hospital
Modern acute care medicine is eye-wateringly complex and potentially dangerous. It really can't be delivered safely without deliberately addressing our teamwork (in both acute and chronic situations). Unfortunately, historically, human factors were commonly left to chance, and recently have been threatened by decerebrate checklists and meaningless psychobabble. Practical strategies exist (thank goodness!) and will be reviewed. We have much to learn, but must also avoid overly simple answers to exceedingly complex problems. It's time to get back to basics and away from the BS. Come be part of a practical revolution
Table of specifications
The document provides guidance for writing test items and creating a table of specification. It explains that a table of specification is a two-way chart that describes the topics to be covered on a test and the number of items or points associated with each topic, to ensure all elements of a course of study are properly assessed. It also defines different levels of thinking skills - knowledge, comprehension, application, analysis, synthesis, and evaluation.
Little Book of Leadership Powerpoint
The document repeatedly lists the URL www.TheLeadershipHub.com over multiple lines without any other text or context. It can be summarized as a document that solely contains the repeated listing of a single website URL address.
Brain Rules for Presenters
Vision trumps all other senses. We have better recall for visual information. Pictures beat text - recognition soars with pictures. Exercise boosts brain power. We don't pay attention to boring things and attention steadily drops after 10 minutes, so presenters should change gears every 10 minutes.
Fashion
Fashion designing is the art of applying design and aesthetics to clothing and accessories. It is influenced by various cultural and social factors and has varied over time and place. Some of the top fashion designers in the world include Valentino Garavani, Tom Ford, Betsey Johnson, Domenico Dolce and Stefano Gabbana, and Stella McCartney. Fashion also has a large industry in India, with top Indian designers being Ritu Beri, Rohit Bal, Rina Dhaka, Manish Malhotra, and Abu Jani and Sandeep Khosla. Fashion is showcased through important fashion shows, represented by famous brands, and brought to the public through magazines
Viewers also liked (11)
Communicate To Connect - The New Rules of Communication
Communicate To Connect - The New Rules of Communication
Interprofessional Communication: Challenges and Opportunities - Walter Eppich
Interprofessional Communication: Challenges and Opportunities - Walter Eppich
Similar to Drug law & regulations
Evolution of Medications
This document discusses the evolution and regulation of medicinal drugs. It covers the major areas of pharmacology, terminology used in drug development and use, substances that have changed medicine, reasons for medication use, routes of drug administration, sources of drugs and their effects, legislation around controlled substances, the phases of clinical drug trials, and FDA regulation including pregnancy risk categories.
Drug Use, Regulation, and the LawChapter 3Guid.docx
This document discusses guidelines for controlling drug development and marketing, including strategies for preventing drug abuse through supply reduction, inoculation, and demand reduction. It also summarizes regulations that have been implemented related to drug labeling, safety testing, and advertising in response to issues like fraudulent patent medicines and the thalidomide tragedy. Current drug scheduling is explained based on abuse potential and medical usefulness.
Labelling of drugs cosmetics nd biotech
This document discusses the labeling and advertising requirements for drugs. It covers topics such as the definitions of drugs and different drug types (OTC and prescription), labeling requirements, information that must be included on labels, and regulations regarding advertising. It also discusses the roles of regulatory bodies like the FDA and FTC in overseeing drug labeling and advertising.
Regulatory requirements for otc drugs as per usfda
Over-the-counter (OTC) drugs are medicines that can be sold directly to consumers without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for use without medical supervision. The FDA approves OTC drugs either through the OTC monograph system, which regulates well-established ingredients by therapeutic class, or through the new drug application process for products that do not fit existing monographs. Regulations cover manufacturing, clinical testing, facility registration, importation, safety monitoring, and risk management for both OTC and prescription drugs.
Introduction to the Legal Basis for Generic Drug Approvals
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009, at Teva Parenterals, with a focus on how the 1984 Hatch-Waxman Act came to be enacted.
Lecture one, units 1 2 pharm
This document provides an overview of the history and key concepts of pharmacology. It discusses:
1) The origins of pharmacology in herbal medicine and its modern emergence in the 19th century with early discoveries like morphine.
2) The role of nurses in safely administering medications and understanding how they work in the body.
3) The FDA approval process including preclinical testing, clinical trials, new drug applications, and postmarketing surveillance.
4) Key definitions like therapeutic classification and controlled substances, and how drugs are named, scheduled and regulated.
Chapter 3 drug regulation and control
The document outlines the history and key pieces of legislation regulating drugs in the United States, beginning with the 1906 Pure Food and Drug Act which aimed to prohibit misbranded and adulterated drugs. Major laws included the 1938 Federal Food, Drug, and Cosmetic Act which gave the FDA power to ensure drug safety, the 1970 Controlled Substances Act which classified drugs into schedules based on abuse potential, and the 1996 Health Insurance Portability and Accountability Act (HIPAA) which provided privacy protections for patient health information. The legislation established the FDA and DEA and granted them authority to approve, schedule, and regulate drugs.
Phtrainerjob2
The document discusses various types and settings of pharmacy practice. It mentions that about 2/3 of pharmacy technicians work in retail settings, while others may work in hospitals, manufacturing, nuclear pharmacies, disease management, mail order pharmacies, or for insurance companies. It also lists some common pharmacy certifications and degrees.
Food drug and cosmetic act 1938
The Federal Food, Drug, and Cosmetic Act (FFDCA) was enacted in 1938 and gave the U.S. Food and Drug Administration (FDA) authority to oversee food, drugs, and cosmetics. It was passed in response to the 1937 Elixir Sulfanilamide tragedy that killed over 100 people. The FFDCA introduced requirements for pre-market approval of new drugs and mandated that labels disclose ingredients and directions for safe use. It has since been amended multiple times to both strengthen and clarify the FDA's regulatory authority.
Counterfeiting prescription drugs
The document discusses the issue of counterfeit prescription drugs, particularly those imported from other countries. It notes that while the FDA's drug distribution system in the US is considered the safest in the world, the number of counterfeit drug cases has risen in recent years. The FDA ordered drugs from a website claiming to offer cheaper generics from Canada, but testing showed the drugs actually came from China and were either too strong or weak, or contained dangerous impurities. Importing drugs from other countries is not safe and raises legal and health issues.
ANDA FDA APPLICATION
The document discusses the process of drug development and approval, including the role of generic drugs. It covers the following key points:
1. There are 5 stages of drug development from discovery to post-marketing trials. Generic drugs can enter after patents and exclusivity expire through an abbreviated approval process requiring only proof of bioequivalence rather than full clinical trials.
2. The Hatch-Waxman Act of 1984 aimed to balance incentives for innovation with increased generic competition. It established provisions for patent term extensions and periods of marketing exclusivity for innovators as well as an abbreviated approval pathway for generics.
3. Generics must file an ANDA demonstrating bioequivalence to the reference drug and can
Hanson 10e Pp Ts Ch03
The document discusses the history of drug regulation laws in the United States from the early 1900s to present day. It covers major milestones like the 1906 Pure Food and Drug Act, the Food, Drug and Cosmetic Act of 1938, and the Controlled Substances Act of 1970 which categorized drugs based on their medical use and abuse potential. The challenges around balancing public health, crime prevention, and civil liberties in developing drug laws are also examined.
Marijuana and the Practice of Real Estate
Realtor clock hour class: Marijuana and the Practice of Real Estate. For students of Jillayne Schlicke's Washington State Realtor Clock Hour Class.
CE Forward, Inc.
Ethics chapter
The document discusses several key legal and ethical issues related to pharmacology and medication administration for nurses. It covers the nurse's responsibilities to understand each medication, adhere to safety procedures like the "5 rights", and report any errors. It also summarizes various US laws governing drug legislation, approval processes, and scheduling of controlled substances.
Pharma 1
The document provides an introduction to pharmacology and drugs. It discusses sources of drugs, how drugs are evaluated, and legal regulation of drugs. It also covers controlled substances schedules, generic drugs, sources of drug information, how drugs act in the body through pharmacodynamics and pharmacokinetics, factors influencing drug effects, toxic and adverse effects of drugs.
Hatch- waxman act (The drug price competition and patent term restoration act...
The Drug Price Competition and Patent Term Restoration Act , informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.
Otc drugs
Over-the-counter (OTC) drugs are medications that can be safely used without a prescription. In the US, the FDA regulates OTC drugs to ensure they are safe and effective for self-treatment of common health issues. The FDA reviews OTC products and establishes labeling regulations. There are two pathways for legal OTC drug marketing: compliance with an OTC drug monograph or approval under a new drug application. OTC drugs are generally low risk for abuse and allow for wider access and treatment of minor conditions. Proper labeling, safety, efficacy, and manufacturing standards are required of all OTC drugs.
Anda for generic drugs in Regulatory affairs
This document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the history and legislation supporting generic drugs. The key points covered include:
- ANDA is an application to the FDA to manufacture and market a generic drug in the US that is equivalent to an approved brand name drug.
- ANDAs are abbreviated because generic drugs do not require clinical trials and provide less information than an NDA for a new drug.
- The objectives of ANDAs are to reduce drug prices, reduce development time, and increase bioavailability compared to reference listed drugs.
- Generic drugs must be identical to the brand name drug in active ingredients, route of administration, dosage
Recall of ph product
This document discusses return and recall of pharmaceutical products. It defines recall as an action taken to remove defective drugs from distribution or use. Recalls are classified based on their health hazard level. Reasons for recall include adverse reactions, GMP failures, and product complaints. The objectives, types (voluntary and statutory), classification, procedures, and timelines of recalls are described. Some major recalls in history like Rofecoxib, Cerivastatin, and Valdecoxib due to increased heart risks are also summarized.
Sharon Roberts' Tips on the DSCSA in FL
This presentation by Sharon Roberts outlines the effects of the Federal Drug Supply Chain and Security Act, or DSCSA or the Drug Quality and Security Act, DQSA and its effects on entities licensed by the State of Florida Department of Business and Professional Regulation and Drug Device and Cosmetics Program. To see more from Sharon Roberts, CDR and attorney visit her site at http://sharonroberts.org/
Similar to Drug law & regulations (20)
Drug Use, Regulation, and the LawChapter 3Guid.docx
Drug Use, Regulation, and the LawChapter 3Guid.docx
Regulatory requirements for otc drugs as per usfda
Regulatory requirements for otc drugs as per usfda
Introduction to the Legal Basis for Generic Drug Approvals
Introduction to the Legal Basis for Generic Drug Approvals
Hatch- waxman act (The drug price competition and patent term restoration act...
Hatch- waxman act (The drug price competition and patent term restoration act...
More from Diana Rangaves, PharmD, CEO
Why Do We Discriminate? Unlearning Behavior Patterns
This document discusses discrimination and how patterns of behavior are learned. It mentions mirror neurons, which fire both when an action is performed and observed, allowing habits and behaviors to be reinforced. Discrimination occurs through domestication, genetic inheritance, and mental negligence. By containing "poisonous" cancer cells with healthy cells, the spread of cancer could potentially be stopped.
Apprenticeship patterns
Physiology and integrative disciplines behind learning patterns. Instructors may freely conduct students to cooperate, interrelate, and create fresh thought network links by writing directly in the work-text. Learning opportunities and reading strategies are incorporated to capture the process. Interactive Keywords, Think-Aloud, Think-Pair-Share, Talking to the Text, Questions, and Mapping in pairs, groups, and individually create a unique relationship with the material and work-text.
Always Reach for the Stars
The article encourages readers to pursue ambitious goals and dreams, as limiting oneself will only result in regret. While the path is difficult, taking small steps each day and persevering through challenges will help one eventually "reach for the stars" and realize what may have once seemed impossible. Achieving great things requires believing in oneself and one's ability to accomplish more than what seems reasonably within reach.
Cancer and Chemotherapy
This document discusses cancer and chemotherapy. It begins by defining cancer as abnormal cells that do not stop dividing. It then lists the top causes of cancer deaths in the United States for males and females. Next, it identifies nine avoidable risk factors that cause one third of cancer deaths, such as smoking and obesity. The document goes on to explain what chemotherapy is and describes how chemotherapy drugs work to destroy cancer cells. It provides examples of different types of chemotherapy drugs and their mechanisms of action. Finally, it discusses some complications of cancer and chemotherapy treatment, including pain, nausea, and mouth sores.
Topical, Opthalmic, Otic
This document discusses various topical, ophthalmic, and otic agents used to treat diseases of the skin, eyes, and ears. It covers common skin conditions like acne, psoriasis, and fungal infections. It also reviews agents for treating eye diseases such as glaucoma and conjunctivitis. Finally, it lists commonly used ear drops for conditions like wax buildup and infections.
Hormones
This document discusses several endocrine-related topics:
1) Diabetes, including types, symptoms, treatment with insulin or oral medications, and long-term complications.
2) Osteoporosis, including risk factors, effects of the disease, and pharmacologic treatments like bisphosphonates.
3) Reproductive hormones like estrogen, contraceptives, and emergency contraception.
Nutritional Needs & Supplements
Nutritional Needs & Supplements
Fluids
Electrolytes
Total Parenteral Nutrition
Natural Supplements
Emergencies
This document discusses cardiac emergencies, poisons and antidotes, and emergency procedures. It covers CODE Blue emergencies to communicate life-threatening situations where a patient's heart or breathing has stopped. It lists agents for cardiac emergencies like amiodarone, digoxin, and epinephrine. Common poisoning agents include iron sulfate, TCAs, and opiates. Supportive care for poisonings includes gastric lavage, activated charcoal, and selected antidotes tailored to the poison ingested.
Biologic Agents of Warfare
This document discusses several biological agents that have been considered for use in biological warfare, categorized by the CDC. Category A agents, which pose the highest risk, include anthrax, plague, smallpox, tularemia, and viral hemorrhagic fevers. Smallpox was eradicated in 1977 but samples are stored by the CDC and Russia. Anthrax spores can survive in soil for years and were used in a 2001 bioterrorism attack in the US. Plague is primarily found in rodents and transmitted by fleas; it was responsible for the Black Death pandemic in the 14th century.
Arthritis & Non-Narcotic Analgesics
This document discusses various types of non-narcotic analgesics and muscle relaxants used to treat pain associated with arthritis. It covers disease-modifying antirheumatic drugs and biological DMARDs for rheumatoid arthritis, corticosteroids and their adverse effects, treatments for osteoarthritis and gout, and the traditional stepped care approach to pain management. Specific drugs mentioned include baclofen, carisoprodol, chlorzoxazone, cyclobenzaprine, diazepam, methocarbamol, orphenadrine, azathioprine, cyclophosphamide, hydroxychloroquine, leflunomide, methotrexate, penicillamine, gold salts,
Antiviral Retrovirals Fungi
The document discusses various topics related to viral infections and treatments. It begins by defining some key terminology used to describe antiviral drugs. It then provides examples of common viral infections like influenza and the common cold. It discusses the lifecycle of viruses and how they infect cells. The document outlines prevention and treatment strategies for influenza. It also lists some other common viral infections and names of antiviral drugs used to treat various conditions. It provides statistics on HIV/AIDS cases in the US and discusses the stages of HIV disease. It maps out the classes of antiretroviral drugs and potential side effects of treatment. Lastly, it stresses the importance of healthy lifestyle behaviors for managing chronic viral conditions long-term.
Love Cocktail
This document discusses the introduction to pharmacology and covers several key topics including receptors, chemical messengers, and the mechanism of drug action. It also briefly mentions romantic euphoria and brain chemistry.
Anesthetics, Analgesics & Narcotics
This document discusses pain management and anesthetics. It covers topics like general anesthesia, local anesthetics, opioids, non-opioid pain relievers, and the treatment of migraines. It also examines non-drug pain management techniques and provides an overview of headache classification and therapeutic agents for treatment.
Administration of Pharmacologic Agents
This document discusses key concepts related to pharmacology administration including prescription elements, dosage forms, routes of administration, allergic reactions, and the body's natural chemical response. It outlines the five rights of drug administration, common abbreviations used in prescriptions, different prescription elements, and reasons for various routes of drug delivery. The document also describes the four types of allergic reactions, examples of causing agents, and treatments. Finally, it discusses the roles of histamines, prostaglandins, and leukotrienes in the body's inflammatory response.
Pharmacology courses online
Pharmacology: Professor Diana Rangaves, Santa Rosa Junior College PHARM 255 and PHARMM 256.1
Pharmacology is a branch of medicine that deals with the study of how drugs affect the body and brain. Studying drugs and their effects, side effects, and how they work, we are able to learn how to treat, manage and prevent disease and illness.
In the study of these chemicals we look at the biological systems affected. This micro neural network of dendrites, neurons, receptors, chemical signaling all involved in the transmission of cellular communication. The field of pharmacology has substantially changed the way we view medications, disease and healing.
Viewed as a Dance Party it has become possible to design chemicals that act on specific cellular signaling or metabolic pathways which control cell function and dysfunction. Knowing how drugs work is all the more important when it comes to serious conditions, life-threatening diseases and suffering. In these cases, knowing the specific actions of each drug before they are administered to patients leads to the highest possible outcome and patient medication safety.
The primary neurotransmitters, Dopamine, Acetylcholine, GABA and Serotonin govern a broad range of clinical pharmacology, neuropharmacology, psychopharmacology, pharmacogenetics, pharmacogenomics, toxicology, posology, and behavioral and environmental pharmacology. These disciplines continue to grow and evolve.
The field encompasses the best pathway to treat illness, disease and prevention; with an emphasis on pharmacokinetics and dynamics, mechanisms of action, clinical use, adverse reactions, drug interactions, contraindications, patient education and compliance.
The courses are organized by modules. Each module has reading, videos, discussion posts and interactive case work to make it real. As facilitator, I curate the discussion, pulling out lines of inquiry and insights as they emerge.
These interactions that occur between a living organism and chemicals are at the foundation of our human care and outcomes.
Continuing education
drangaves@santarosa.edu
http://online.santarosa.edu/homepage/drangaves
Skills That Matter
This document discusses skills and characteristics important for leadership and organizational change. It emphasizes the need for a common purpose and vision shared by all stakeholders, clear communication, developing people, and making decisions. It also stresses the importance of understanding the environment, both internal leaders and external communities, and setting a course for strategic change while gaining buy-in and commitment through transparency, engagement, and follow through during cultural transition. The final sections note that organizations must be willing to change and adapt or risk being left behind, and that opportunities should be seized through action rather than speculation.
Proof-Of-Concept
Proof-of-Concept a education, training and framework method for creativity, open heart leadership and the Courage to be Extraordinary!
Seeing Beyond
This is an educational training designed for organizations, executives and employees who desire Excellence. In doing so, gaining awareness of the bigger picture.
Sunflowers
This document discusses improving leadership, employee engagement, and organizational performance. It addresses the following key points:
1. Leaders should seek feedback from employees and be open-minded to different perspectives. Accountability, clear goals and metrics, and aligning human capital plans with business outcomes are also emphasized.
2. Developing leadership, entrepreneurial, life, and coping skills in employees can reduce turnover. The hiring process also needs improvement.
3. Fostering creativity, empathy, questioning the status quo, cross-pollination of ideas, and qualitative employee support can increase engagement. Simple interactions build trust which is important.
More from Diana Rangaves, PharmD, CEO (20)
Why Do We Discriminate? Unlearning Behavior Patterns
Why Do We Discriminate? Unlearning Behavior Patterns
Recently uploaded
Histololgy of Female Reproductive System.pptx
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Know the difference between Endodontics and Orthodontics.
Your smile is beautiful.
Let’s be honest. Maintaining that beautiful smile is not an easy task. It is more than brushing and flossing. Sometimes, you might encounter dental issues that need special dental care. These issues can range anywhere from misalignment of the jaw to pain in the root of teeth.
Acute Gout Care & Urate Lowering Therapy .pdf
In this document , the management of acute gout attacks and a description of urate lowering therapy is mentioned.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.Artificial Intelligence Symposium (THAIS)
Artificial Intelligence Symposium (THAIS). Parc Taulí. Sabadell
How to choose the best dermatologists in Indore.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Pharmacology of 5-hydroxytryptamine and Antagonist
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Hemodialysis: Chapter 5, Dialyzers Overview - Dr.Gawad
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
What are the different types of Dental implants.
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Travel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Skin Diseases That Happen During Summer.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
Top Travel Vaccinations in Manchester
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdf
Time-lapse embryo monitoring is an advanced imaging technique used in IVF to continuously observe embryo development. It captures high-resolution images at regular intervals, allowing embryologists to select the most viable embryos for transfer based on detailed growth patterns. This technology enhances embryo selection, potentially increasing pregnancy success rates.
Recently uploaded (20)
Tele Optometry (kunj'sppt) / Basics of tele optometry.
Tele Optometry (kunj'sppt) / Basics of tele optometry.
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
Know the difference between Endodontics and Orthodontics.
Know the difference between Endodontics and Orthodontics.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
Pharmacology of 5-hydroxytryptamine and Antagonist
Pharmacology of 5-hydroxytryptamine and Antagonist
Hemodialysis: Chapter 5, Dialyzers Overview - Dr.Gawad
Hemodialysis: Chapter 5, Dialyzers Overview - Dr.Gawad
Travel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff: Health Advice for International Travelers
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdf
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdf
Drug law & regulations
- 1. Development of Drug Regulations FDA Food & Drug Administration FTC Federal Trade Commission DEA Drug Enforcement Agency
Editor's Notes
- Forms, ordering, disposal, storage