This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
Pharmacovigilance involves monitoring the effects of medications after they have been approved for use. It aims to detect, assess, understand, and prevent adverse effects. The field has grown in importance due to limitations of clinical trials and examples of drugs that caused harm after approval. Pharmacovigilance processes involve collecting adverse event reports from healthcare professionals and patients, analyzing the reports for signals of potential safety issues, and taking action if needed. India has established pharmacovigilance programs to help ensure the safe use of drugs within the country.
Pharmacovigilance & Adverse drug reactionRahul Bhati
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
This document discusses pharmacovigilance, which involves monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify adverse effects early. It defines key terms like adverse events, adverse reactions, and signals. It describes the WHO program for international drug monitoring and India's national pharmacovigilance program. The pharmacovigilance process involves data collection and management, signal detection, risk assessment, benefit-risk assessment, risk communication, and audit. Various methods for data collection and signal detection are discussed.
This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
Pharmacovigilance involves monitoring the effects of medications after they have been approved for use. It aims to detect, assess, understand, and prevent adverse effects. The field has grown in importance due to limitations of clinical trials and examples of drugs that caused harm after approval. Pharmacovigilance processes involve collecting adverse event reports from healthcare professionals and patients, analyzing the reports for signals of potential safety issues, and taking action if needed. India has established pharmacovigilance programs to help ensure the safe use of drugs within the country.
Pharmacovigilance & Adverse drug reactionRahul Bhati
This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
This document discusses pharmacovigilance, which involves monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify adverse effects early. It defines key terms like adverse events, adverse reactions, and signals. It describes the WHO program for international drug monitoring and India's national pharmacovigilance program. The pharmacovigilance process involves data collection and management, signal detection, risk assessment, benefit-risk assessment, risk communication, and audit. Various methods for data collection and signal detection are discussed.
Pharmacovigilance involves monitoring the safety of drugs at all stages, from development through post-marketing. It aims to detect, understand, and prevent adverse drug reactions through activities like adverse event reporting, drug monitoring, and studying medication errors and drug-related deaths. Pharmacovigilance is important for protecting public health as patterns of drug use change over time with globalization and advances in technology and medicine.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to improve patient safety by detecting adverse drug reactions and assessing risk-benefit profiles of drugs. Pharmacovigilance involves collecting reports of adverse drug events from healthcare professionals and patients. These reports are analyzed to code reactions, assess causality and seriousness, and detect safety signals. Regulatory authorities use pharmacovigilance data to inform risk management strategies and product labeling. International collaboration helps establish standardized practices and share safety information globally. While pharmacovigilance is important for prescription drugs, special considerations apply to monitoring the safety of herbal medicines due to quality issues.
Pharmacovigilance involves monitoring drugs for adverse effects to improve patient safety. It is important due to risks like those seen with thalidomide. Adverse drug reactions can be classified by onset, frequency, severity and mechanism. Pharmacovigilance systems help prevent future harm by increasing knowledge of drug safety issues. Drug interactions and adverse reactions and require monitoring to prevent negative health outcomes.
Regulatory terminologies used in PV (Pharmacovigilance)MubasheeraMg
This document defines various regulatory terminologies used in pharmacovigilance (PV). It defines key terms like pharmacovigilance, adverse drug reactions, clinical trials, causality assessment, and data mining. It also provides definitions for terms related to evaluating drug safety like absolute risk, incidence, benefits, harms, and effectiveness/risk analysis. Regulatory organizations involved in PV like CIOMS, ICH, and MedDRA are also defined.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they have been approved for public use. PMS is important because clinical trials have limitations in terms of patient population size, duration, and ability to detect rare or long-term effects. Sources of PMS information include spontaneous reporting, studies using medical databases, and manufacturer monitoring. Common PMS methods include spontaneous reporting of adverse drug reactions, cohort studies, and case control studies. PMS can help identify new safety issues and provide more information on drug risks and benefits in diverse patient populations.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
This document discusses pharmacotherapy and rational drug use. It explains that pharmacotherapy aims to safely and effectively manage drug administration based on an understanding of pharmacokinetics and pharmacodynamics to optimize dosing for each patient. Rational drug use requires that patients receive appropriate medications, doses, treatment duration and lowest cost. Irrational drug use can result in treatment failure, increased toxicity and drug resistance. The document outlines various factors that influence drug use and can lead to irrational prescribing, dispensing and non-adherence.
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
- Zehra Ashraf presented on the topic of pharmacovigilance.
- Pharmacovigilance involves assessing, detecting, understanding, and preventing adverse drug reactions. It works through processes like adverse drug reaction reporting and analysis.
- The history of pharmacovigilance began in the early 1900s with laws being passed in response to drug safety issues. Global pharmacovigilance systems have developed and expanded since the mid-1900s.
- Methods of pharmacovigilance include spontaneous reporting of adverse reactions, cohort event monitoring, and periodic safety update reports. Pharmacovigilance is also important during clinical trials and after drug approval.
This document provides guidelines for physicians, pharmacists, nurses and medical auxiliaries on essential drugs. It includes an introduction by the Director of the World Health Organization's Essential Drugs and Other Medicines department, as well as sections on the editorial committee, contributors, preface, foreword, and use of the guide.
Abacavir is an antiretroviral used in combination with other drugs to treat HIV-1 and HIV-2 infections. It is administered orally in tablet or liquid form, with dosages depending on weight and age. Abacavir can cause hypersensitivity reactions and should not be given to patients with severe liver impairment or a history of intolerance to the drug.
A pharmacologist has several key roles:
1. Medical education - Teaching undergraduate and postgraduate students about rational drug use, effects, toxicity, and interactions.
2. Research - Conducting both basic and clinical research, ensuring adherence to guidelines for clinical trials and ethical reviews.
3. Regulatory affairs - Involved in essential drug lists, national drug policy, and regulatory bodies like drug authorities.
This document analyzes reporting of adverse drug reactions (ADRs) by pharmacists in the Pharmacovigilance Programme of India (PvPI) between July 2011 and December 2014. It finds that of 110,000 reports in the database, 16,646 (15%) were reported by pharmacists. Of these, 3,782 (22.7%) were serious reactions while 9,601 (57.7%) were non-serious. Reporting by pharmacists has increased over time. The document concludes that pharmacists can play an important role in pharmacovigilance by detecting, reporting, and assessing ADRs.
Ich (s5 r2) The International Council for Harmonisationof Technical Requireme...AMIT KUMAR
GUIDLINES FOR REPRODUCTIVE TOXICOLOGY,Strategies for reproductive toxicity assessment,The International Council for Harmonisation,of Technical Requirements for Pharmaceuticals for Human Use
Pharmacovigilance involves monitoring the safety of drugs at all stages, from development through post-marketing. It aims to detect, understand, and prevent adverse drug reactions through activities like adverse event reporting, drug monitoring, and studying medication errors and drug-related deaths. Pharmacovigilance is important for protecting public health as patterns of drug use change over time with globalization and advances in technology and medicine.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to improve patient safety by detecting adverse drug reactions and assessing risk-benefit profiles of drugs. Pharmacovigilance involves collecting reports of adverse drug events from healthcare professionals and patients. These reports are analyzed to code reactions, assess causality and seriousness, and detect safety signals. Regulatory authorities use pharmacovigilance data to inform risk management strategies and product labeling. International collaboration helps establish standardized practices and share safety information globally. While pharmacovigilance is important for prescription drugs, special considerations apply to monitoring the safety of herbal medicines due to quality issues.
Pharmacovigilance involves monitoring drugs for adverse effects to improve patient safety. It is important due to risks like those seen with thalidomide. Adverse drug reactions can be classified by onset, frequency, severity and mechanism. Pharmacovigilance systems help prevent future harm by increasing knowledge of drug safety issues. Drug interactions and adverse reactions and require monitoring to prevent negative health outcomes.
Regulatory terminologies used in PV (Pharmacovigilance)MubasheeraMg
This document defines various regulatory terminologies used in pharmacovigilance (PV). It defines key terms like pharmacovigilance, adverse drug reactions, clinical trials, causality assessment, and data mining. It also provides definitions for terms related to evaluating drug safety like absolute risk, incidence, benefits, harms, and effectiveness/risk analysis. Regulatory organizations involved in PV like CIOMS, ICH, and MedDRA are also defined.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they have been approved for public use. PMS is important because clinical trials have limitations in terms of patient population size, duration, and ability to detect rare or long-term effects. Sources of PMS information include spontaneous reporting, studies using medical databases, and manufacturer monitoring. Common PMS methods include spontaneous reporting of adverse drug reactions, cohort studies, and case control studies. PMS can help identify new safety issues and provide more information on drug risks and benefits in diverse patient populations.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
This document discusses pharmacotherapy and rational drug use. It explains that pharmacotherapy aims to safely and effectively manage drug administration based on an understanding of pharmacokinetics and pharmacodynamics to optimize dosing for each patient. Rational drug use requires that patients receive appropriate medications, doses, treatment duration and lowest cost. Irrational drug use can result in treatment failure, increased toxicity and drug resistance. The document outlines various factors that influence drug use and can lead to irrational prescribing, dispensing and non-adherence.
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
- Zehra Ashraf presented on the topic of pharmacovigilance.
- Pharmacovigilance involves assessing, detecting, understanding, and preventing adverse drug reactions. It works through processes like adverse drug reaction reporting and analysis.
- The history of pharmacovigilance began in the early 1900s with laws being passed in response to drug safety issues. Global pharmacovigilance systems have developed and expanded since the mid-1900s.
- Methods of pharmacovigilance include spontaneous reporting of adverse reactions, cohort event monitoring, and periodic safety update reports. Pharmacovigilance is also important during clinical trials and after drug approval.
This document provides guidelines for physicians, pharmacists, nurses and medical auxiliaries on essential drugs. It includes an introduction by the Director of the World Health Organization's Essential Drugs and Other Medicines department, as well as sections on the editorial committee, contributors, preface, foreword, and use of the guide.
Abacavir is an antiretroviral used in combination with other drugs to treat HIV-1 and HIV-2 infections. It is administered orally in tablet or liquid form, with dosages depending on weight and age. Abacavir can cause hypersensitivity reactions and should not be given to patients with severe liver impairment or a history of intolerance to the drug.
A pharmacologist has several key roles:
1. Medical education - Teaching undergraduate and postgraduate students about rational drug use, effects, toxicity, and interactions.
2. Research - Conducting both basic and clinical research, ensuring adherence to guidelines for clinical trials and ethical reviews.
3. Regulatory affairs - Involved in essential drug lists, national drug policy, and regulatory bodies like drug authorities.
This document analyzes reporting of adverse drug reactions (ADRs) by pharmacists in the Pharmacovigilance Programme of India (PvPI) between July 2011 and December 2014. It finds that of 110,000 reports in the database, 16,646 (15%) were reported by pharmacists. Of these, 3,782 (22.7%) were serious reactions while 9,601 (57.7%) were non-serious. Reporting by pharmacists has increased over time. The document concludes that pharmacists can play an important role in pharmacovigilance by detecting, reporting, and assessing ADRs.
Ich (s5 r2) The International Council for Harmonisationof Technical Requireme...AMIT KUMAR
GUIDLINES FOR REPRODUCTIVE TOXICOLOGY,Strategies for reproductive toxicity assessment,The International Council for Harmonisation,of Technical Requirements for Pharmaceuticals for Human Use
The presentation is about the dose selection for laboratory animal toxicology drug testing, explaining staged and staggered approach of dose selection.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Estimating the Maximum Safe Starting Dose for First-in-Human Clinical TrialsMaRS Discovery District
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Beatrice Setnik
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
Pharmacovigilance involves monitoring adverse drug reactions (ADRs) that are detected after drugs receive marketing approval. ADRs are defined as harmful effects from normal drug dosages. Several types of ADRs exist and can be serious or severe. Possible causes include drug interactions and underlying medical conditions. Reporting and monitoring ADRs through pharmacovigilance aims to improve patient safety and reduce risks from drug use.
Effetti a lungo termine dell'associazione a dose fissa di latanoprost e timol...Merqurio
This prospective study observed 2339 patients with glaucoma or ocular hypertension who were switched to latanoprost/timolol fixed combination therapy for at least 18 months. The primary reasons for switching were inadequate intraocular pressure (IOP) reduction and desire for once-daily dosing. IOP was effectively reduced and maintained over 24 months. Optic disc and visual field assessments showed stability. Physicians rated the fixed combination as effective, well-tolerated, and that patients were compliant with the treatment regimen.
This document summarizes the 43rd Annual meeting of the European Teratology Society. It discusses new FDA labeling requirements for pregnancy and lactation information, including removing pregnancy categories and providing risk summaries. It outlines the specific content requirements for sections 8.1 on Pregnancy, 8.2 on Lactation, and 8.3 on Females and Males of Reproductive Potential. Timelines are provided for applications to conform to the new requirements. Presentations are described on inflammation in pregnancy and effects on fetal development, and using zebrafish embryos for chemical screening.
Pharmacogenomics aims to optimize drug therapy based on a patient's genotype. Genetic factors can account for 20-95% of variability in drug response. Polymorphisms like SNPs that occur in over 1% of a population can impact drug metabolism and effects. Pharmacogenomic testing targets biomarkers for specific drug classes to determine efficacy and avoid toxicity. While it has potential to improve prescribing, limitations include many genes influencing drugs and ethical issues. Personalized medicine based on pharmacogenomics is still developing.
The document discusses pharmacogenetics, which is the study of how genetic factors affect individual responses to drugs. It begins by defining pharmacogenetics and explaining why it is important. Then it outlines the goals of pharmacogenetics, which include maximizing drug efficacy and minimizing toxicity. It also discusses how genetic variations like single nucleotide polymorphisms can impact how individuals metabolize and respond to certain drugs. The document notes the roles of pharmacogenetics in drug development, clinical practice, and precision medicine. It concludes by stating that pharmacogenetics has potential to optimize drug therapy and enable more personalized treatment approaches.
UPDATED-Early Phase Drug Developmetn and Population PK and Its' ValueE. Dennis Bashaw
Presentation Given at Regional AAPS DDDI Meeting in Baltimore. Similar to previous talks BUT updated to include a discussion of BIA 10-2474 and extended discussion of risk
Adverse drug reactions, Drug interactions, Drug discovery and clinical evalua...Dr Ravikiran S
This document discusses adverse drug reactions and pharmacovigilance. It defines adverse drug reactions as any noxious change suspected to be caused by a drug. Adverse reactions are classified as predictable or unpredictable. Predictable reactions are based on the pharmacological properties of the drug, while unpredictable reactions are based on patient peculiarities. The severity of adverse drug reactions is also graded.
The document then discusses the process of pharmacovigilance, which involves monitoring adverse drug reactions post-marketing through voluntary reporting systems and disseminating data on reactions to healthcare professionals. Pharmacovigilance centers analyze reported reactions and provide expertise in assessing causality and severity. The goals of pharmacovigilance are detection, understanding and
- Toxicology is the scientific study of adverse effects of chemicals on living organisms. It involves observing and reporting symptoms, mechanisms, detection and treatments of toxic substances in relation to human poisoning.
- The OECD promotes policies to improve economic and social well-being worldwide. It works with governments to understand drivers of change and sets international standards on issues like agriculture, tax, and chemical safety. India has cooperated with the OECD since 1995 through enhanced engagement programs.
- Toxicity testing involves various studies including acute, sub-acute, sub-chronic, chronic, and special toxicity (carcinogenicity) testing over different time periods. Chronic toxicity testing identifies target organs and characterizes dose-response relationships
Phase 1 clinical trials are the first studies conducted in humans of a new drug or treatment. They aim to determine the drug's safety and tolerability, identify the maximum tolerated dose, and understand the drug's pharmacokinetics. Phase 1 trials typically involve small groups of healthy volunteers or patients and start with low doses that are gradually increased. The results of phase 1 trials provide information needed to design subsequent phase 2 and 3 trials to further evaluate efficacy.
Environmental Risk Assessment for Pharmaceutical DrugsCovance
Understanding the Evaluation and Implications of Findings to the Regulatory Review of Human Medicines in the Environment. Pharmaceutical drugs are intended for the treatment of human disease, therefore the risk of their environmental exposure in clinical use needs to be evaluated. Environmental risk assessment (ERA) is part of the requirements when applying for marketing approval in many geographic regions throughout the world.
Pharmacogenomics- a step to personalized medicinesApusi Chowdhury
Pharmacogenomics aims to optimize drug therapy based on a patient's genotype to maximize efficacy and minimize adverse effects. It involves studying how genetic factors influence individual responses to drugs in terms of absorption, distribution, metabolism, and excretion. Genetic polymorphisms like SNPs that occur in over 1% of the population can impact a drug's effects. Pharmacogenomic testing identifies biomarkers related to drug metabolism and targets to determine effective treatments and dosages for patients. While it holds promise for improving drug development and personalized medicine, limitations include insufficient validation and high costs.
Similar to Establishing a Veterinary PDE // 3D-PharmXchange (20)
Know the difference between Endodontics and Orthodontics.Gokuldas Hospital
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.
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.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
- 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
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
Discover the benefits of homeopathic medicine for irregular periods with our guide on 5 common remedies. Learn how these natural treatments can help regulate menstrual cycles and improve overall menstrual health.
Visit Us: https://drdeepikashomeopathy.com/service/irregular-periods-treatment/
Pictorial and detailed description of patellar instability with sign and symptoms and how to diagnose , what investigations you should go with and how to approach with treatment options . I have presented this slide in my 2nd year junior residency in orthopedics at LLRM medical college Meerut and got good reviews for it
After getting it read you will definitely understand the topic.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
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.
1. Establishing a Permitted Daily Exposure
for Veterinary Medicinal Products
3D-PharmXchange
19-Nov-2015
2. PDE
Veterinary Medicinal Products
EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012)
Current: Cleaning is a risk-reducing measure and carry-over limits for cleaning
validation studies are widely used in the pharmaceutical industry. A variety of
approaches are taken in order to establish these limits and often do not take
account of the available pharmacological and toxicological data.
New approach: Review and evaluation of pharmacological and toxicological data of
individual active pharmaceutical ingredients (API) enables determination of
science-based threshold levels
3. Product A
Subject: Unintended patient/person, target animal
PDE: Permitted Daily Exposure
“a dose that is unlikely to cause an adverse effect if an individual is exposed, by any
route, at or below this dose every day over a lifetime”
PDE
Veterinary Medicinal Products
4. Product A Product B
Cross-contamination
Drug product
Risk
- Target animals
- Patient population
- Consumers of food producing
animals
à To be implemented for all medicinal products in shared manufacturing facilities*
PDE
(permitted daily exposure)
Shared Facility Guideline
Medicinal products provide a benefit to the intended patient or target animal, however
as a cross contaminant, they provide no benefit to the patient or target animal and may
even pose a risk
* Often excluding therapeutic macromolecules and peptides
RiskAssessment
PDE
Veterinary Medicinal Products
5. Dose/day
PDE = ------------------------------ = XXX mg/kg/day
F1 * F2 * F3 * F4 * F5
PDE (permitted daily exposures)Veterinary PDE
Ø It is possible to use the PDE approach to
establish different limits for different target
species, however, due to the impracticability
of it and considering a pragmatic approach,
PDEs should be derived assuming human
exposure.
Ø In case of food producing animals, neither
the target animal nor the consumer should
be exposed to residual active substance
levels exceeding the PDE
PDE
Veterinary Medicinal Products
6. F is 1 – 12 (ICH Q3C)
F1 = A factor to account for extrapolation between species
• Factor 1 – 12, based on body surface conversion
• Not all species assessed
F2 = A factor of 10 to account for variability between individuals
• Option to use 15 for sensitive patient subpopulations
F3 = A variable factor to account for toxicity studies of short-term
exposure
• Factor 1, 2, 5, 10
• Life-long (rodent/non-rodent) versus study duration: acute,
chronic, organogenesis (reprotoxicity)
F4 = A factor that may be applied in cases of severe toxicity
• Factor 1, 5, 10
• Potential subjective assessment of ‘severe’ in studies other
than those described in the guideline (i.e. reprotoxicity)
F5 = A variable factor that may be applied if the no-observed-effect-
level ‘NOEL’ was not established
• Factor 1-10
• E.g. NOEL(1)/NOAEL(1-5), LOEL(5-10)/LOAEL(10)
PDE: F factoren
Dose/day
PDE = ------------------------------ = XXX mg/kg/day
F1 * F2 * F3 * F4 * F5
PDE (permitted daily exposures)
PDE
Veterinary Medicinal Products
8. Non-clinical
Safety pharmacology, Repeated dose toxicity,
Genotoxicity, Carcinogenicity, Reprotoxicity
Sensitization
Clinical
Pharmacological effects
Dosing regimen
Adverse Events - severity / incidence
Critical effects / PDE selection
• Which data?
o Internal/external public literature
o US product label/EU SPC
o Use of old (non-GLP) data?
“The conservative approach in the EU may reflect the central
position of the SPC in risk management of new pharmaceuticals.
A typical feature of the US PI was the detailed description of the
efficacy and safety result of the pivotal clinical trials”
Nieminen et al, 2005
Information necessary
PDE
Veterinary Medicinal Products
9. Non-clinical
Safety pharmacology, Repeated dose toxicity,
Genotoxicity, Carcinogenicity, Reprotoxicity
Sensitization
Clinical
Pharmacological effects
Dosing regimen
Adverse Events - severity / incidence
Critical effects / PDE selection
o Which (repeated dose) studies to include?
o Are the non-clinical findings biologically relevant? How do
you assess significance of non-clinical versus clinical
findings?
o Threshold of toxicological concern (TTC): 1.5 μg/day for
substances which pose a chemical risk for potential
genotoxicity
Note:
à Staged TTC (less than lifetime (LLT)) is possible depending
on dosing frequency/duration
à For veterinary medicines the TTC can be indicated per kg
weight (e.g. for a 50 kg animal the TTC of 1.5 μg/day would
be 0.03 μg/kg/day)
PDE: documenten
Information necessary
PDE
Veterinary Medicinal Products
10. Non-clinical
Safety pharmacology, Repeated dose toxicity,
Genotoxicity, Carcinogenicity, Reprotoxicity
Sensitization
Clinical
Pharmacological effects
Dosing regimen
Adverse Events - severity / incidence
Critical effects / PDE selection
o How do you determine the lowest dose?
Ø Difference in dose/kg or per dose/patient
Ø E.g. surface area for dermal application (FTU-finger
tip unit)
o Multiple dosing regimens and routes of exposure possible
for one drug
Ø Consider accumulation
Ø Extrapolation: dermal/oral/inhalation/parenteral
(bioavailability % / assumed absorption [100%]) x PDE
PDE: documenten
Information necessary
PDE
Veterinary Medicinal Products
11. Non-clinical
Safety pharmacology, Repeated dose toxicity,
Genotoxicity, Carcinogenicity, Reprotoxicity
Sensitization
Clinical
Pharmacological effects
Dosing regimen
Adverse Events - severity / incidence
Critical effects / PDE selection
o Target population (unintended exposure patient)
o Sensitive human subpopulations:
Ø Liver/kidney failure
Ø Pediatrics/Geriatrics
Ø Sex (hormones)
o Selection of critical effect
Ø Serious Adverse Event (consider incidence)
Ø ‘Common’ Adverse Event : target organ system (e.g.
gastrointestinal tract, CNS etc.)
Information necessary
PDE
Veterinary Medicinal Products
12. Non-clinical
Safety pharmacology, Repeated dose toxicity,
Genotoxicity, Carcinogenicity, Reprotoxicity
Sensitization
Clinical
Pharmacological effects
Dosing regimen
Adverse Events - severity / incidence
Critical effects / PDE selection
o Report all pivotal human and animal critical effects
o Include justification for F factors
o Select
Ø the lowest/most conservative PDE
Ø or the most appropriate, i.e. most sensitive (and
relevant) indicator of an adverse effect
Information necessary
PDE
Veterinary Medicinal Products