TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxAnmolkanda06
This document discusses toxicokinetics evaluation and saturation kinetics in preclinical studies. It defines toxicokinetics and its primary and secondary objectives in preclinical testing according to ICH guidelines. It outlines the general principles and types of toxicokinetic studies conducted at different stages of preclinical development, including safety assessment studies, single/rising dose studies, repeated dose toxicity studies, genotoxicity studies, reproduction toxicity studies, and carcinogenicity studies. It also discusses saturation kinetics, how non-linear pharmacokinetics can occur due to saturation of absorption, distribution, metabolism or excretion processes, and how non-linearity is detected.
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.
Toxicological Approach to Drug DiscoverySuhas Reddy C
This document outlines the toxicological approach to drug development. It discusses the importance of conducting various toxicity studies at different stages of drug development to ensure safety. These include single dose, repeated dose, fertility, reproductive, developmental and genotoxicity studies in animals. It describes the typical safety program involving staged approach and discusses factors to consider in designing toxicity studies. The goal is to obtain sufficient non-clinical safety data to support clinical trials and assess safety for human use.
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.
The document summarizes the stages of drug development from discovery through clinical trials and regulatory approval. It describes 10 main stages: 1) discovery and development, 2) preclinical research, 3) investigational new drug application, 4) clinical research including 3 phases of trials, 5) FDA review and approval, and 6) post-market safety monitoring. Preclinical research involves testing for safety and efficacy in animal and lab models. If promising, the drug enters clinical trials with humans starting with small Phase 1 safety studies, then Phase 2 dosing studies, and larger Phase 3 trials to confirm efficacy before the FDA reviews the final application for approval. The overall process takes around 10-15 years from discovery to patients.
This document provides guidelines for safety pharmacology and toxicology studies for pharmaceutical products. It outlines the objectives and types of studies recommended at different stages of clinical development, including safety pharmacology core battery studies, follow-up studies, reproductive and developmental toxicity studies, and human studies. Test systems, dose levels, durations, endpoints, and good laboratory practice standards are discussed for each type of nonclinical study.
TOXICOKINETICS EVALUATION IN PRECLINICAL STUDIES.pptxAnmolkanda06
This document discusses toxicokinetics evaluation and saturation kinetics in preclinical studies. It defines toxicokinetics and its primary and secondary objectives in preclinical testing according to ICH guidelines. It outlines the general principles and types of toxicokinetic studies conducted at different stages of preclinical development, including safety assessment studies, single/rising dose studies, repeated dose toxicity studies, genotoxicity studies, reproduction toxicity studies, and carcinogenicity studies. It also discusses saturation kinetics, how non-linear pharmacokinetics can occur due to saturation of absorption, distribution, metabolism or excretion processes, and how non-linearity is detected.
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.
Toxicological Approach to Drug DiscoverySuhas Reddy C
This document outlines the toxicological approach to drug development. It discusses the importance of conducting various toxicity studies at different stages of drug development to ensure safety. These include single dose, repeated dose, fertility, reproductive, developmental and genotoxicity studies in animals. It describes the typical safety program involving staged approach and discusses factors to consider in designing toxicity studies. The goal is to obtain sufficient non-clinical safety data to support clinical trials and assess safety for human use.
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.
The document summarizes the stages of drug development from discovery through clinical trials and regulatory approval. It describes 10 main stages: 1) discovery and development, 2) preclinical research, 3) investigational new drug application, 4) clinical research including 3 phases of trials, 5) FDA review and approval, and 6) post-market safety monitoring. Preclinical research involves testing for safety and efficacy in animal and lab models. If promising, the drug enters clinical trials with humans starting with small Phase 1 safety studies, then Phase 2 dosing studies, and larger Phase 3 trials to confirm efficacy before the FDA reviews the final application for approval. The overall process takes around 10-15 years from discovery to patients.
This document provides guidelines for safety pharmacology and toxicology studies for pharmaceutical products. It outlines the objectives and types of studies recommended at different stages of clinical development, including safety pharmacology core battery studies, follow-up studies, reproductive and developmental toxicity studies, and human studies. Test systems, dose levels, durations, endpoints, and good laboratory practice standards are discussed for each type of nonclinical study.
This document discusses the process of generating safety data during drug development. It describes the three main phases - drug discovery, preclinical, and clinical trial phases. The preclinical phase involves pharmacodynamics, pharmacokinetic, and toxicological studies in animals over 1.5-2 years. These studies evaluate absorption, distribution, metabolism, excretion, toxicity, and help establish a safety profile before human trials. The clinical trial phase involves 4 phases to test safety and efficacy in humans. After approval, phase 4 surveillance continues to monitor performance and adverse effects through periodic safety reports.
This document outlines the principles and types of non-clinical toxicity studies conducted in animals prior to testing pharmaceuticals in humans. It discusses general principles like complying with Good Laboratory Practice, using standardized equipment and protocols. It also describes the different types of toxicology studies including toxicokinetic, reproductive toxicity, teratogenicity and perinatal studies. The goal is to assess safety and predict potential adverse effects in humans by administering test substances to animals and observing toxicity.
New drug development is a long and expensive process that can take over 10 years and cost $500-1000 million. It involves drug discovery, preclinical testing in animals, and clinical trials in humans divided into phases. Preclinical testing assesses safety, efficacy, and side effects in animal models and isolated tissues over 2-4 years. If results are promising, clinical trials in human volunteers and patients are initiated to further evaluate safety and efficacy over 3-10 years before regulatory approval and marketing. The overall process aims to discover and optimize drug candidates, evaluate safety and efficacy, and gain regulatory approval for marketing new pharmaceutical treatments.
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.
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.
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.
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.
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity 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.
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.
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.
This document discusses various toxicokinetic studies conducted in preclinical stages of drug development. It describes conducting single dose, rising dose, repeated dose toxicity studies in rodents and non-rodents to determine kinetic parameters and assess safety. The importance of toxicokinetic data in setting safe clinical doses is highlighted. Alternative methods to animal testing like in vitro, in silico, cell line techniques and patch clamp method are also summarized.
This document provides guidelines for safety pharmacology studies for human pharmaceuticals from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidelines discuss the objectives, scope, general principles, test systems, experimental design, dose levels/concentrations, duration of studies, and studies on metabolites for safety pharmacology evaluations. The goal is to help protect clinical trial participants and patients by identifying potential adverse effects of pharmaceuticals early in development.
This document provides an overview of the drug development process, which includes early drug discovery through preclinical research on animals, clinical trials with human subjects in four phases, regulatory review and approval, and post-marketing safety surveillance. The process aims to determine if a new drug is safe, effective for its intended use, and has the proper dosage before it can reach patients, and typically takes over a decade. Key steps include identifying drug targets, developing and screening candidate compounds, optimizing leads, conducting preclinical and clinical trials to test safety and efficacy, obtaining regulatory approval, and ongoing monitoring after approval.
A review on stages of drug development and alternative methods for animal stu...Frinto Francis
Various Stages of drug development, anaesthesia ,euthanasia, animals used for preclinical analysis, clinical trials, alternative methods for animal testing, blood withdrawal methods, ethical guidelines
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
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.
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.
This document discusses various types of animal toxicity studies conducted prior to clinical use of drugs in humans. It provides objectives and details of reproductive and developmental toxicity studies, local toxicity studies, carcinogenicity studies, and genotoxicity studies. Reproductive toxicity studies examine effects on fertility and development in offspring. Developmental toxicity studies evaluate effects during pregnancy and across lifespan. Local toxicity studies are required when drugs are administered via non-oral routes. Carcinogenicity studies identify substances that may induce or increase tumors.
Toxicokinetic evaluation in preclinical studies.pptxARSHIKHANAM4
1. Toxicokinetics is the study of how toxic substances are affected by the body in terms of absorption, distribution, metabolism, and excretion. It applies pharmacokinetic principles to doses used in toxicology testing.
2. The primary objective of toxicokinetic evaluation in preclinical studies is to describe systemic exposure levels in animals and relate this to toxicity findings to assess clinical safety. Secondary objectives include supporting species and dose selection for toxicity studies.
3. Toxicokinetic data is collected in various required preclinical safety studies, including repeat-dose toxicity studies, reproduction toxicity studies, and genotoxicity studies, to interpret results and demonstrate drug exposure.
This document discusses the process of generating safety data during drug development. It describes the three main phases - drug discovery, preclinical, and clinical trial phases. The preclinical phase involves pharmacodynamics, pharmacokinetic, and toxicological studies in animals over 1.5-2 years. These studies evaluate absorption, distribution, metabolism, excretion, toxicity, and help establish a safety profile before human trials. The clinical trial phase involves 4 phases to test safety and efficacy in humans. After approval, phase 4 surveillance continues to monitor performance and adverse effects through periodic safety reports.
This document outlines the principles and types of non-clinical toxicity studies conducted in animals prior to testing pharmaceuticals in humans. It discusses general principles like complying with Good Laboratory Practice, using standardized equipment and protocols. It also describes the different types of toxicology studies including toxicokinetic, reproductive toxicity, teratogenicity and perinatal studies. The goal is to assess safety and predict potential adverse effects in humans by administering test substances to animals and observing toxicity.
New drug development is a long and expensive process that can take over 10 years and cost $500-1000 million. It involves drug discovery, preclinical testing in animals, and clinical trials in humans divided into phases. Preclinical testing assesses safety, efficacy, and side effects in animal models and isolated tissues over 2-4 years. If results are promising, clinical trials in human volunteers and patients are initiated to further evaluate safety and efficacy over 3-10 years before regulatory approval and marketing. The overall process aims to discover and optimize drug candidates, evaluate safety and efficacy, and gain regulatory approval for marketing new pharmaceutical treatments.
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.
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.
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.
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.
Assignment on Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity 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.
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.
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.
This document discusses various toxicokinetic studies conducted in preclinical stages of drug development. It describes conducting single dose, rising dose, repeated dose toxicity studies in rodents and non-rodents to determine kinetic parameters and assess safety. The importance of toxicokinetic data in setting safe clinical doses is highlighted. Alternative methods to animal testing like in vitro, in silico, cell line techniques and patch clamp method are also summarized.
This document provides guidelines for safety pharmacology studies for human pharmaceuticals from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidelines discuss the objectives, scope, general principles, test systems, experimental design, dose levels/concentrations, duration of studies, and studies on metabolites for safety pharmacology evaluations. The goal is to help protect clinical trial participants and patients by identifying potential adverse effects of pharmaceuticals early in development.
This document provides an overview of the drug development process, which includes early drug discovery through preclinical research on animals, clinical trials with human subjects in four phases, regulatory review and approval, and post-marketing safety surveillance. The process aims to determine if a new drug is safe, effective for its intended use, and has the proper dosage before it can reach patients, and typically takes over a decade. Key steps include identifying drug targets, developing and screening candidate compounds, optimizing leads, conducting preclinical and clinical trials to test safety and efficacy, obtaining regulatory approval, and ongoing monitoring after approval.
A review on stages of drug development and alternative methods for animal stu...Frinto Francis
Various Stages of drug development, anaesthesia ,euthanasia, animals used for preclinical analysis, clinical trials, alternative methods for animal testing, blood withdrawal methods, ethical guidelines
clinical and preclinical approaches to drug discovery.Here we mainly deals with preclinical approaches, ie. Pharmacological approach and toxicological approach
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.
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.
This document discusses various types of animal toxicity studies conducted prior to clinical use of drugs in humans. It provides objectives and details of reproductive and developmental toxicity studies, local toxicity studies, carcinogenicity studies, and genotoxicity studies. Reproductive toxicity studies examine effects on fertility and development in offspring. Developmental toxicity studies evaluate effects during pregnancy and across lifespan. Local toxicity studies are required when drugs are administered via non-oral routes. Carcinogenicity studies identify substances that may induce or increase tumors.
Toxicokinetic evaluation in preclinical studies.pptxARSHIKHANAM4
1. Toxicokinetics is the study of how toxic substances are affected by the body in terms of absorption, distribution, metabolism, and excretion. It applies pharmacokinetic principles to doses used in toxicology testing.
2. The primary objective of toxicokinetic evaluation in preclinical studies is to describe systemic exposure levels in animals and relate this to toxicity findings to assess clinical safety. Secondary objectives include supporting species and dose selection for toxicity studies.
3. Toxicokinetic data is collected in various required preclinical safety studies, including repeat-dose toxicity studies, reproduction toxicity studies, and genotoxicity studies, to interpret results and demonstrate drug exposure.
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This presentation by OECD, OECD Secretariat, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
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Suzanne Lagerweij - Influence Without Power - Why Empathy is Your Best Friend...Suzanne Lagerweij
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This session will use Dave Gray’s Empathy Mapping, Argyris’ Ladder of Inference and The Four Rs from Agile Conversations (Squirrel and Fredrick).
Abstract:
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We can combine our innate empathy with our analytical skills to gain a deeper understanding of complex situations at work. Join this session to learn how to prepare for difficult conversations and how to improve our agile conversations in order to be more influential without power. We will use Dave Gray’s Empathy Mapping, Argyris’ Ladder of Inference and The Four Rs from Agile Conversations (Squirrel and Fredrick).
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Come learn more on how to become a real influencer!
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This presentation was uploaded with the author’s consent.
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This presentation was uploaded with the author’s consent.
2. Toxicokinetics is defined as the generation of pharmacokinetics data to
design, conduct & Interpretation drug safety evaluation studies.In
preclinical drug safety evaluation or toxicological studies, a minimum of
two animal species are employed, as per regulation of the FDA.
1. Rodents
e.g:-Rats, Mice.
2. Non-rodents
e.g:-Dog
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 2
3. 1. Safety assessment:
Generally, the safety of a molecule can be performed in in-vivo systems.
This step is not included in the guidelines but it is very useful for the
researchers to assess the systemic exposure. This safety study is an integral part
of the CNS, CVS, and respiratory assessments.
2. Single dose and rising dose studies :
Studies performed in the very early stage of drug development before a
bioanalytical method. These studies are usually performed in rodents.Plasma
samples are taken and stored for later analysis
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 3
4. 3. Repeated-dose toxicity studies :
To give support for phase 1 studies this study is carried out for four
weeks in both rodents as well as non-rodents. Help to support dose selection
for subsequent studies. Performing further repeated dose studies in both rodents
and non-rodents up to 6-12 months enables estimation of the drug and its
metabolite kinetic parameter assessment as well as long-term clinical exposure
assessment.
4. Genotoxicity studies :
Two in vitro studies and one in vivo study are essential to support the
development of drug. In vivo investigations usually use a rodent micronucleus
(bone marrow or peripheral erythrocytes) test or chromosome aberration (bone
marrow cells) test.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 4
5. 5. Reproduction toxicity studies :
Reproduction toxicity measurements are taken in studies of fertility (rat),
embryo-fetal development (rat and rabbit), and pre-or post-natal development
(rat).
6. Studies of fertility:
Assessment of fertility toxicity is very important because most of the drugs used in
fertility conditions have to strengthen at that time. Usually, this can be done in rats.
7. In pregnant and lactating animals:
There is a regulatory expectation for toxicokinetic data in pregnant animals,
although no specific guidance is given. Toxicokinetics may involve exposure
assessment of dams, embryos, foetuses, or newborns on specified days. Secretion
in milk may be assessed to define its role in the exposure of newborns. In some
situations, additional studies may be necessary or appropriate in order to study
embryo/foetal transfer and secretion in milk.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 5
11. 1. Important in drug development stages especially in the preclinical stage.
2. TK evaluation is useful for setting safe dose levels in clinical phases.
3. TK evaluation is useful in the selection of dose, dosing form, alternative dosing route, and
evaluation of toxicological mechanism, and also used for setting safe dose levels in clinical
phases.
4. TK studies are also used to reduce the animal number.
5. TK evaluation is very important in the drug development phase from both regulatory and
scientific perspectives.
6. TK data are practically used for the purpose of drug discovery such as lead-optimization
and candidate-selection.
7. Toxicokinetic data is important to know the toxic response to drug exposure obtained in
drug development stages.
8. It is used to set safe doses for clinical use of new drugs.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 11
12. Screening of anti-cancer drugs.
Cell-based bioassays.
To determine the cytotoxicity.
In vitro screening of several drugs.
Production of anti viral vaccines
Cancer research, which require the study of uncontrolled cell division in culture.
Cell fusion technique.
Genetic manipulation.
Gene therapy.
Recombinant DNA therapy.
Biotechnology.
ANSARI AASHIF RAZA {M PHARM 1 YEAR} 12