This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
The document discusses the general principles of pre-clinical studies. It describes the steps involved which include identifying a drug target, developing a bioassay to test the drug, screening the drug in the assay, and establishing the effective and toxic doses. It also discusses the types of pre-clinical studies like pharmacodynamics, pharmacokinetics and toxicity studies that are required before different phases of clinical trials. The common methods of screening drugs in pre-clinical studies are in-vitro, in-vivo, ex-vivo and in-silico methods.
1. An Investigational New Drug (IND) application is required for testing an experimental drug in humans and must be submitted to regulatory agencies like the FDA for approval.
2. The IND application contains preclinical research data on animal and microbiological studies as well as clinical trial protocols, manufacturing information, and investigator details.
3. There are different types of INDs including commercial, non-commercial, emergency use, and treatment INDs which have varying requirements and purposes in the drug development process.
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
An IND application is submitted to the FDA to request permission to conduct clinical trials on an investigational new drug. It contains preclinical animal and toxicity data, manufacturing information, and clinical trial protocols and investigator information. The FDA reviews the IND over 30 days to ensure the protection of human subjects and that the investigational plan allows for evaluation of safety and effectiveness. Clinical trials cannot begin until the IND is approved or the 30-day review period has ended without FDA objection. Sponsors must submit annual reports updating the FDA on the progress of investigations under the IND.
Establishing Pharmacovigilance Centres In Hospital.pptxRushikeshTidake
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
Severity, seriousness, predictability and preventability assessmentDr. Ramesh Bhandari
This document discusses the assessment of severity and seriousness of adverse drug reactions (ADRs). It defines severity as the intensity of a medical event, categorizing ADRs as mild, moderate or severe based on management steps. It also describes several classification scales for ADR severity, including one by Karch and Lasagna and the Modified Hartwig's and Siegel Scale. The document defines seriousness classification according to regulatory criteria. It then discusses preventability and predictability of ADRs, describing scales by Schumock and Thornton for preventability and the distinction between Type A and Type B reactions in terms of predictability.
Preclinical studies are conducted before human trials to assess pharmacological and toxicological effects. Both in vitro and in vivo studies characterize these effects. Preclinical testing aims to detect toxicity, understand hazards, establish dose responses, and assess distribution, metabolism, and carcinogenicity. It involves short and long term animal studies in two species, as well as safety pharmacology, toxicology, developmental and reproductive toxicity testing, and genetic and carcinogenicity studies. The steps of preclinical trials include identifying a drug target, developing a bioassay, screening compounds, establishing effective and toxic doses, and filing for investigational new drug approval.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
The document discusses the general principles of pre-clinical studies. It describes the steps involved which include identifying a drug target, developing a bioassay to test the drug, screening the drug in the assay, and establishing the effective and toxic doses. It also discusses the types of pre-clinical studies like pharmacodynamics, pharmacokinetics and toxicity studies that are required before different phases of clinical trials. The common methods of screening drugs in pre-clinical studies are in-vitro, in-vivo, ex-vivo and in-silico methods.
1. An Investigational New Drug (IND) application is required for testing an experimental drug in humans and must be submitted to regulatory agencies like the FDA for approval.
2. The IND application contains preclinical research data on animal and microbiological studies as well as clinical trial protocols, manufacturing information, and investigator details.
3. There are different types of INDs including commercial, non-commercial, emergency use, and treatment INDs which have varying requirements and purposes in the drug development process.
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
An IND application is submitted to the FDA to request permission to conduct clinical trials on an investigational new drug. It contains preclinical animal and toxicity data, manufacturing information, and clinical trial protocols and investigator information. The FDA reviews the IND over 30 days to ensure the protection of human subjects and that the investigational plan allows for evaluation of safety and effectiveness. Clinical trials cannot begin until the IND is approved or the 30-day review period has ended without FDA objection. Sponsors must submit annual reports updating the FDA on the progress of investigations under the IND.
Establishing Pharmacovigilance Centres In Hospital.pptxRushikeshTidake
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
Severity, seriousness, predictability and preventability assessmentDr. Ramesh Bhandari
This document discusses the assessment of severity and seriousness of adverse drug reactions (ADRs). It defines severity as the intensity of a medical event, categorizing ADRs as mild, moderate or severe based on management steps. It also describes several classification scales for ADR severity, including one by Karch and Lasagna and the Modified Hartwig's and Siegel Scale. The document defines seriousness classification according to regulatory criteria. It then discusses preventability and predictability of ADRs, describing scales by Schumock and Thornton for preventability and the distinction between Type A and Type B reactions in terms of predictability.
Preclinical studies are conducted before human trials to assess pharmacological and toxicological effects. Both in vitro and in vivo studies characterize these effects. Preclinical testing aims to detect toxicity, understand hazards, establish dose responses, and assess distribution, metabolism, and carcinogenicity. It involves short and long term animal studies in two species, as well as safety pharmacology, toxicology, developmental and reproductive toxicity testing, and genetic and carcinogenicity studies. The steps of preclinical trials include identifying a drug target, developing a bioassay, screening compounds, establishing effective and toxic doses, and filing for investigational new drug approval.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
The WHO International Drug Monitoring Program was established in 1963 in response to the thalidomide disaster. It currently has 143 member countries that submit adverse drug reaction reports to the global pharmacovigilance database VigiBase managed by the Uppsala Monitoring Centre (UMC) as a WHO collaborating center. The UMC analyzes VigiBase data to identify new safety signals, conducts research, and provides tools and training to support member countries' pharmacovigilance activities. The overall goals are to identify unknown adverse drug reactions and ensure medicines are used safely worldwide.
Anatomical, therapeutic and chemical classification of drugs.pptxReshmaManeDeshmukh
This document discusses the Anatomical Therapeutic Chemical (ATC) classification system for drugs. It provides details on the different levels of the classification system and examples to illustrate how a drug is classified. The ATC system divides active substances into 14 main anatomical groups according to the organ or system they act on. Drugs are further classified into subgroups at five different levels including the chemical substance. The document also outlines the inclusion and exclusion criteria for classifying drugs in the ATC system, which is established and maintained by the WHO collaborating centre in Oslo.
1. Unit I - new drug discovery and development.Audumbar Mali
The document summarizes the stages of drug discovery and development. It begins with drug discovery, which involves understanding disease pathways and identifying drug targets. Lead compounds are then identified and optimized. Preclinical testing assesses safety. If successful, an investigational new drug application is filed and clinical trials proceed in four phases, from initial safety testing to large efficacy trials. If approved, post-marketing monitoring continues to assess long-term safety. The process aims to bring safe and effective therapies to patients while adhering to regulatory standards.
The document discusses various approaches to drug discovery, including pharmacological, toxicological, and preclinical trials. It describes the components of pharmacological evaluation including selectivity testing, pharmacological profiling in vitro and in vivo, and safety pharmacology testing of major organ systems like central nervous system, cardiovascular, and respiratory systems. The goal of preclinical trials is to determine if a new drug works and is safe to test in humans using animal models and evaluating its pharmacological effects, toxicity, and safety pharmacologically.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
Drug safety evaluation in clinical trialVikas Sharma
This document discusses drug safety evaluation in clinical trials. It provides an overview of safety concerns, sources of safety information, safety monitoring and reporting requirements. Safety is evaluated using data from nonclinical studies, clinical trials and postmarketing reports. Adverse events are monitored and assessed for causality. Serious adverse events must be reported expediently to regulatory agencies. Ongoing evaluation is needed to identify unexpected or rare safety issues.
Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTIONAnindya Banerjee
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical trials have multiple phases and are carefully designed studies used to test new treatments and evaluate their safety and efficacy in humans. Phase 1 trials involve 10-100 healthy participants and focus on safety, while Phase 2 trials involve 50-500 patient participants to explore effectiveness. Phase 3 trials involve 1000-3000 patients to confirm safety and efficacy. Phase 4 trials monitor treatments after approval when used by thousands of patients. In total, the clinical trial process from discovery to approval takes an average of 6-7 years and involves Phases 0-3 trials followed by Phase 4 post-marketing surveillance.
This document discusses the importance of monitoring medicine safety after drugs receive marketing approval. It notes that while drugs are tested on limited populations before approval, they are then used by much larger and more diverse populations. Close monitoring of medicine effectiveness and safety under real-world conditions is necessary to identify expected and unexpected adverse reactions. Effective pharmacovigilance requires collaboration between government agencies, the pharmaceutical industry, healthcare providers, patients, and others to establish comprehensive monitoring systems.
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.
This document discusses drug therapy monitoring and pharmaceutical care. It outlines the key components and goals of drug therapy monitoring including medication order review, clinical review, and pharmacist intervention. The goals are to optimize drug therapy, prevent medication errors, and assess therapeutic outcomes. It also discusses the process of pharmaceutical care which involves identifying drug-related problems, determining treatment goals, developing and implementing care plans, and monitoring outcomes. The overall aim is to provide responsible drug therapy to improve patients' quality of life.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pre-clinical screening involves testing potential new drugs in animal models before human trials to evaluate safety and efficacy. This includes pharmacological screening to determine mechanism of action and dose response, as well as toxicological testing to identify adverse effects and calculate safe starting doses for clinical trials. Studies progress from molecular and cellular assays to whole animal experiments. Acute and repeated dose toxicity tests are followed by sub-chronic and chronic studies to identify long-term effects. These pre-clinical studies aim to generate data required to deem a new compound safe enough for initial human testing.
n drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
New Drug Discovery And Development (part-2)swatisejwani
The document discusses the steps involved in preclinical trials for new drug development. Preclinical trials involve laboratory and animal testing to evaluate safety and efficacy before human testing. Key steps include: identifying a drug target and developing a bioassay; screening the drug in the bioassay; establishing effective and toxic doses; filing for Investigational New Drug approval with the FDA; and conducting various studies like toxicity, pharmacokinetic, and animal model testing under Good Laboratory Practice standards. The goal of preclinical trials is to obtain sufficient safety and efficacy data to justify moving a drug into clinical trials with human subjects.
The WHO International Drug Monitoring Program was established in 1963 in response to the thalidomide disaster. It currently has 143 member countries that submit adverse drug reaction reports to the global pharmacovigilance database VigiBase managed by the Uppsala Monitoring Centre (UMC) as a WHO collaborating center. The UMC analyzes VigiBase data to identify new safety signals, conducts research, and provides tools and training to support member countries' pharmacovigilance activities. The overall goals are to identify unknown adverse drug reactions and ensure medicines are used safely worldwide.
Anatomical, therapeutic and chemical classification of drugs.pptxReshmaManeDeshmukh
This document discusses the Anatomical Therapeutic Chemical (ATC) classification system for drugs. It provides details on the different levels of the classification system and examples to illustrate how a drug is classified. The ATC system divides active substances into 14 main anatomical groups according to the organ or system they act on. Drugs are further classified into subgroups at five different levels including the chemical substance. The document also outlines the inclusion and exclusion criteria for classifying drugs in the ATC system, which is established and maintained by the WHO collaborating centre in Oslo.
1. Unit I - new drug discovery and development.Audumbar Mali
The document summarizes the stages of drug discovery and development. It begins with drug discovery, which involves understanding disease pathways and identifying drug targets. Lead compounds are then identified and optimized. Preclinical testing assesses safety. If successful, an investigational new drug application is filed and clinical trials proceed in four phases, from initial safety testing to large efficacy trials. If approved, post-marketing monitoring continues to assess long-term safety. The process aims to bring safe and effective therapies to patients while adhering to regulatory standards.
The document discusses various approaches to drug discovery, including pharmacological, toxicological, and preclinical trials. It describes the components of pharmacological evaluation including selectivity testing, pharmacological profiling in vitro and in vivo, and safety pharmacology testing of major organ systems like central nervous system, cardiovascular, and respiratory systems. The goal of preclinical trials is to determine if a new drug works and is safe to test in humans using animal models and evaluating its pharmacological effects, toxicity, and safety pharmacologically.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
Drug safety evaluation in clinical trialVikas Sharma
This document discusses drug safety evaluation in clinical trials. It provides an overview of safety concerns, sources of safety information, safety monitoring and reporting requirements. Safety is evaluated using data from nonclinical studies, clinical trials and postmarketing reports. Adverse events are monitored and assessed for causality. Serious adverse events must be reported expediently to regulatory agencies. Ongoing evaluation is needed to identify unexpected or rare safety issues.
Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTIONAnindya Banerjee
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical trials have multiple phases and are carefully designed studies used to test new treatments and evaluate their safety and efficacy in humans. Phase 1 trials involve 10-100 healthy participants and focus on safety, while Phase 2 trials involve 50-500 patient participants to explore effectiveness. Phase 3 trials involve 1000-3000 patients to confirm safety and efficacy. Phase 4 trials monitor treatments after approval when used by thousands of patients. In total, the clinical trial process from discovery to approval takes an average of 6-7 years and involves Phases 0-3 trials followed by Phase 4 post-marketing surveillance.
This document discusses the importance of monitoring medicine safety after drugs receive marketing approval. It notes that while drugs are tested on limited populations before approval, they are then used by much larger and more diverse populations. Close monitoring of medicine effectiveness and safety under real-world conditions is necessary to identify expected and unexpected adverse reactions. Effective pharmacovigilance requires collaboration between government agencies, the pharmaceutical industry, healthcare providers, patients, and others to establish comprehensive monitoring systems.
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.
This document discusses drug therapy monitoring and pharmaceutical care. It outlines the key components and goals of drug therapy monitoring including medication order review, clinical review, and pharmacist intervention. The goals are to optimize drug therapy, prevent medication errors, and assess therapeutic outcomes. It also discusses the process of pharmaceutical care which involves identifying drug-related problems, determining treatment goals, developing and implementing care plans, and monitoring outcomes. The overall aim is to provide responsible drug therapy to improve patients' quality of life.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pre-clinical screening involves testing potential new drugs in animal models before human trials to evaluate safety and efficacy. This includes pharmacological screening to determine mechanism of action and dose response, as well as toxicological testing to identify adverse effects and calculate safe starting doses for clinical trials. Studies progress from molecular and cellular assays to whole animal experiments. Acute and repeated dose toxicity tests are followed by sub-chronic and chronic studies to identify long-term effects. These pre-clinical studies aim to generate data required to deem a new compound safe enough for initial human testing.
n drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
New Drug Discovery And Development (part-2)swatisejwani
The document discusses the steps involved in preclinical trials for new drug development. Preclinical trials involve laboratory and animal testing to evaluate safety and efficacy before human testing. Key steps include: identifying a drug target and developing a bioassay; screening the drug in the bioassay; establishing effective and toxic doses; filing for Investigational New Drug approval with the FDA; and conducting various studies like toxicity, pharmacokinetic, and animal model testing under Good Laboratory Practice standards. The goal of preclinical trials is to obtain sufficient safety and efficacy data to justify moving a drug into clinical trials with human subjects.
Introduction to pre clinical screening of drugsKanthlal SK
Various Techniques and Methods for screening of new chemical entities in preclinical aspects (both invitro & invivo) for effective and safe clinical usage.
The document summarizes the new drug development process, which takes 10 years and costs $500-1000 million on average. It involves preclinical studies in animals to test safety and efficacy, followed by clinical trials in humans in four phases to further assess safety and efficacy. If successful in clinical trials, the drug receives marketing approval from regulatory authorities. Post-marketing surveillance continues to monitor long-term safety and effectiveness. The goal is to develop new drugs that are clinically safe and effective as well as economically viable.
Pre-clinical trials involve testing new drugs, procedures, or medical treatments in animals before beginning clinical trials in humans. They aim to determine safety and efficacy. The document outlines the stages of pre-clinical trials including in vitro and in vivo testing, pharmacokinetic studies, toxicity tests, and FDA review requirements. The goals are to identify safe starting doses in humans, target organs for toxicity, and safety parameters for clinical monitoring before human trials.
This document discusses key concepts in pharmaceutics and drug development. It covers:
1. The branches of pharmaceutics including pharmacokinetics, pharmacodynamics, biopharmaceutics, and pharmaceutical technology.
2. The process of drug discovery and development, from identifying drug targets through preclinical and clinical testing.
3. The different phases of clinical trials and timelines for drug approval.
4. The definitions of key terms used in drug development like target, hit, lead, candidate, and product.
5. The differences between brand drugs, generics, and biosimilars.
Pre-clinical and clinical trials are processes used to test drugs and medical devices for safety and efficacy before human use. Pre-clinical trials involve basic research and testing in animals. If promising, an Investigational New Drug application is filed with the FDA to begin clinical trials with humans. Clinical trials are conducted in phases, starting with small safety trials and progressing to large efficacy trials. If successful, final approval is sought from the FDA through a New Drug Application. The entire drug development process from basic research to approval typically takes 12-15 years and costs $100-800 million per drug.
Assignment on Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional, Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT
The document discusses the process of drug discovery and development. It has 5 main stages: drug discovery, pre-clinical testing, clinical trials (phases I-III), regulatory approval, and post-marketing surveillance. Drug discovery involves screening compounds for pharmacological activity through random testing, serendipitous findings, or rational drug design. Pre-clinical testing involves extensive animal studies to evaluate safety, efficacy, and adverse effects. Clinical trials in humans have 3 phases to further assess these factors before regulatory approval and marketing of the drug. Post-approval monitoring continues to study long-term safety and efficacy.
Phase 1 clinical trials are the first studies done in humans of a new drug or treatment. They aim to determine the drug's safety and side effects, identify the maximum tolerated dose, and understand how the body processes the drug through pharmacokinetic evaluation. 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 clinical trial phases that further evaluate efficacy.
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.
DRUG DISCOVERY & DEVELOPMENT PROCESS, it's a detail description about how drug is made available in market it's development and discovery of drug The Hole Study is given in This Topic.
The document outlines the key stages of the drug development process:
1) Discovery, where potential drug candidates are identified through research. 2) Preclinical testing to evaluate safety and efficacy in animal studies. 3) Clinical trials involving human subjects in 3 phases to further assess safety and effectiveness. 4) Regulatory review and approval by agencies like the FDA if the drug is found safe and effective for its intended use. The entire process is lengthy and rigorous, aimed at bringing only beneficial treatments to market.
Preclinical studies are conducted before human trials to assess pharmacological and toxicological effects. Both in vitro and in vivo studies characterize these effects. Preclinical testing aims to detect toxicity, understand hazards, establish dose responses, and assess distribution, metabolism, and carcinogenicity. It involves short and long term animal studies in two species, as well as safety pharmacology, toxicology, developmental and reproductive toxicity testing, and genetic and carcinogenicity studies. The steps of preclinical trials include identifying a drug target, developing a bioassay, screening compounds, establishing effective and toxic doses, and filing for investigational new drug approval.
Stages of drug development by Dr Joseph Oyepata Simeon (Ph.D)oyepata
The document outlines the stages of drug development from discovery through clinical trials and FDA approval. It discusses 4 main stages: 1) Discovery and preclinical research involving animal testing, 2) Clinical research consisting of 4 phases starting with small safety trials and increasing in size, 3) Filing an Investigational New Drug Application with the FDA to begin clinical trials, and 4) Final FDA review and potential approval or denial to market the drug. Only about 25-30% of drugs make it through the entire process, which can take 10-15 years and costs over $2 billion on average.
Preclinical studies, clinical trails and pharmacovigilancekamrudeen samani
The document discusses the various phases of drug development including preclinical, clinical, and post-marketing phases. The preclinical phase involves animal studies to evaluate toxicity, pharmacokinetics, and pharmacodynamics. If promising, the drug enters clinical trials with Phase I studying safety in healthy volunteers, Phase II studying efficacy in patients, and Phase III large scale studies to further confirm safety and efficacy. After approval, Phase IV involves post-marketing surveillance. Pharmacovigilance aims to improve patient safety by monitoring drugs for adverse effects after market entry.
Introduction to drug discovery and development.pptxMingmaLhamuBhutia
The document provides an overview of drug discovery and development. It discusses the various stages including discovery, preclinical research, clinical trials (phases 1-4), regulatory approval, and post-approval surveillance. The discovery stage involves identifying drug targets and lead compounds. Preclinical research involves safety testing in animals. Clinical trials test safety and efficacy in humans in phases. Regulatory agencies approve drugs that are proven safe and effective. Post-approval surveillance monitors drugs after market release. The overall process aims to develop innovative therapies while ensuring patient safety.
Safety pharmacology studies in drug developmentAnkita
In the given ppt we get idea about safety pharmacology studies. learn why safety pharmacology is important. concept of safety pharmacology, also get the knowledge from where safety pharmacology is originated
An Overview of Drug Discovery Processes.pptxSamra Siddiqui
This document provides an overview of the drug discovery process. It describes the key steps as target identification, target validation, compound screening, drug optimization, pre-clinical trials, and clinical trials. Target identification involves finding a biomolecule involved in a disease. Target validation confirms the target's role. Compound screening identifies potential drug candidates. Drug optimization improves properties like potency, efficacy, and safety. Pre-clinical trials test safety in animals. Clinical trials then test in humans through four phases to determine efficacy and safety for regulatory approval. The entire process from discovery to approval typically takes 10-15 years and costs $800 million to $2 billion.
Current Ms word generated power point presentation covers major details about the micronuclei test. It's significance and assays to conduct it. It is used to detect the micronuclei formation inside the cells of nearly every multicellular organism. It's formation takes place during chromosomal sepration at metaphase.
Nucleophilic Addition of carbonyl compounds.pptxSSR02
Nucleophilic addition is the most important reaction of carbonyls. Not just aldehydes and ketones, but also carboxylic acid derivatives in general.
Carbonyls undergo addition reactions with a large range of nucleophiles.
Comparing the relative basicity of the nucleophile and the product is extremely helpful in determining how reversible the addition reaction is. Reactions with Grignards and hydrides are irreversible. Reactions with weak bases like halides and carboxylates generally don’t happen.
Electronic effects (inductive effects, electron donation) have a large impact on reactivity.
Large groups adjacent to the carbonyl will slow the rate of reaction.
Neutral nucleophiles can also add to carbonyls, although their additions are generally slower and more reversible. Acid catalysis is sometimes employed to increase the rate of addition.
BREEDING METHODS FOR DISEASE RESISTANCE.pptxRASHMI M G
Plant breeding for disease resistance is a strategy to reduce crop losses caused by disease. Plants have an innate immune system that allows them to recognize pathogens and provide resistance. However, breeding for long-lasting resistance often involves combining multiple resistance genes
The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions.
Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability.
Our observation is that multiple layers — hardware, operating systems, third-party libraries, software versions, input data, compile-time options, and parameters — are subject to variability that exacerbates frictions but is also essential for achieving robust, generalizable results and fostering innovation. I will first review the literature, providing evidence of how the complex variability interactions across these layers affect qualitative and quantitative software properties, thereby complicating the reproduction and replication of scientific studies in various fields.
I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating).
I will finally argue that deep variability is both the problem and solution of frictionless reproducibility, calling the software science community to develop new methods and tools to manage variability and foster reproducibility in software systems.
Exposé invité Journées Nationales du GDR GPL 2024
The binding of cosmological structures by massless topological defectsSérgio Sacani
Assuming spherical symmetry and weak field, it is shown that if one solves the Poisson equation or the Einstein field
equations sourced by a topological defect, i.e. a singularity of a very specific form, the result is a localized gravitational
field capable of driving flat rotation (i.e. Keplerian circular orbits at a constant speed for all radii) of test masses on a thin
spherical shell without any underlying mass. Moreover, a large-scale structure which exploits this solution by assembling
concentrically a number of such topological defects can establish a flat stellar or galactic rotation curve, and can also deflect
light in the same manner as an equipotential (isothermal) sphere. Thus, the need for dark matter or modified gravity theory is
mitigated, at least in part.
Remote Sensing and Computational, Evolutionary, Supercomputing, and Intellige...University of Maribor
Slides from talk:
Aleš Zamuda: Remote Sensing and Computational, Evolutionary, Supercomputing, and Intelligent Systems.
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Inter-Society Networking Panel GRSS/MTT-S/CIS Panel Session: Promoting Connection and Cooperation
https://www.etran.rs/2024/en/home-english/
ESPP presentation to EU Waste Water Network, 4th June 2024 “EU policies driving nutrient removal and recycling
and the revised UWWTD (Urban Waste Water Treatment Directive)”
The use of Nauplii and metanauplii artemia in aquaculture (brine shrimp).pptxMAGOTI ERNEST
Although Artemia has been known to man for centuries, its use as a food for the culture of larval organisms apparently began only in the 1930s, when several investigators found that it made an excellent food for newly hatched fish larvae (Litvinenko et al., 2023). As aquaculture developed in the 1960s and ‘70s, the use of Artemia also became more widespread, due both to its convenience and to its nutritional value for larval organisms (Arenas-Pardo et al., 2024). The fact that Artemia dormant cysts can be stored for long periods in cans, and then used as an off-the-shelf food requiring only 24 h of incubation makes them the most convenient, least labor-intensive, live food available for aquaculture (Sorgeloos & Roubach, 2021). The nutritional value of Artemia, especially for marine organisms, is not constant, but varies both geographically and temporally. During the last decade, however, both the causes of Artemia nutritional variability and methods to improve poorquality Artemia have been identified (Loufi et al., 2024).
Brine shrimp (Artemia spp.) are used in marine aquaculture worldwide. Annually, more than 2,000 metric tons of dry cysts are used for cultivation of fish, crustacean, and shellfish larva. Brine shrimp are important to aquaculture because newly hatched brine shrimp nauplii (larvae) provide a food source for many fish fry (Mozanzadeh et al., 2021). Culture and harvesting of brine shrimp eggs represents another aspect of the aquaculture industry. Nauplii and metanauplii of Artemia, commonly known as brine shrimp, play a crucial role in aquaculture due to their nutritional value and suitability as live feed for many aquatic species, particularly in larval stages (Sorgeloos & Roubach, 2021).
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
3. INTRODUCTION
Pre-clinical trials is a study to test a drug, a procedure or another
medical treatment in animals
In drug development, pre-clinical development, also named pre-
clinical studies and non-clinical studies, is a stage of research that
begins before clinical trials (testing in humans) can begin, and
during which important feasibility, iterative testing and drug safety
data is collected
It also means invivo or invitro experiments in which test articles are
studied prospectively in test systems under laboratory conditions to
determine their safety
4. HISTORY
The first ever clinical trial was demonstrated by James Lind’s in
1753 that citrus fruits cured scurvy
He compared the effects of various different acidic substances
ranging from vinegar to cider, on groups of sailors, and found that
the group who were given oranges and lemons had largely recovered
from scurvy after 6 days
5. PRE-CLINICAL TRIALS
Definition- a laboratory test of a new drug or a new medical
device, usually done on animal subjects, to see if they hoped for
treatment really works and if it is safe to test on humans
GOALS of this is to;
identify initial safe dose and dose escalation schemes in humans
Identify target organs for toxicity
Study of such toxicity whether reversible
Identify safety parameter for clinical monitoring
8. INVITRO PRE-CLINICAL TRIALS
PHARMACODYNAMICS STUDIES:
Needed for better characterisation by providing evidence for the
desired biological effect of a drug
Providing insight into potential toxicities to establish a human
starting dose
PHARMACOKINETIC STUDY:
The ADME, volume of distribution and half-life of drug are
quantified
9. INVIVO PRE-CLINICAL TRIALS
SCREENING - simple and rapidly performed tests to indicate
presence or absence of a particular activity
ISOLATED ORGAN – study of activity on isolated organ.
Eg: Antipyretics
BACTERIAL CULTURES – study of any activity using bacterial
cultures. Eg: Antibiotics
ANIMAL MODELS – animal models used. Eg: genetically
hypersensitive rats, experimental tuberculosis in mouse
GENERAL OBSERVATIONS – drug is injected in tripling doses
to small groups of mice which are observed for overt (hidden)
effects. Preliminary cluses are drawn from the profile of effect
observed
10. MECHANISM OFACTION – attempts are made to find out the
mechanism of action. Eg: whether an anti-hypertensive is an β
blocker/ α blocker
SYSTEMIC PHARMACOLOGY – irrespective of the primary
action of the drug, its effect on major organ systems such as
nervous, cardio-vascular, respiratory, renal are worked out
QUANTITATIVE TESTS – the dose-response relationship,
maximal effects and comparative efficacy with existing drug is
carried out
CONFIRMATORY TEST – compounds found active are taken up
for detailed study by more elaborate (complex) tests which confirm
and characterize the activity
11. STAGES
Lead selection (like structural characterization, impurity identification,
solubility assessment, prototype formulation, stability testing) and
optimisation (like screening efficacy, early ADME, early toxicology)
Drug candidate confirmation (data from lead selection and optimisation)
Preliminary chemistry, manufacture, control
Invivo models
ADME profiling
Preliminary toxicology
Preclinical drug characteristics (data from previous stage)
Detailed preclinical CMC
Comprehensive ADME
Toxicology package
12. CONSIDERATION FOR TRIALS
Selection of relevant animal species
Age
Physiological state
Manner of delivery
Stability of test material
13. STEPS
Get idea for drug
Develop a bioassay
Screen chemical compounds in assay
Establish effective and toxic amounts
File for approval (leads to clinical trials)