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Animal toxicology studies

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SWATI SARIN
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PHASES OF DRUG DEVELOPMENT (ANIMAL MAN) PHASE III PHASE IV PHASE I PHASE I PRECLINICAL PHASE II Product Approval (NDA/MAA) Patient studies Entry to man (IND / CTA) None Healthy subjects Safety and tolerability Genetic toxicity (in vivo) Repeat dose toxicity testing + Bioanalysis / Toxicokinetics Drug Metabolism Reproductive Toxicity Testing (teratogenicity) Patients Small scale efficacy studies Patients Large scale multicentre studies Chronic (long term) toxicity testing + Bioanalysis / Toxicokinetics Reproductive Toxicity Testing (fertility and pre/post natal) Carcinogenicity studies Drug Metabolism Patients Large scale post-marketing studies As required Genetic toxicity (in vitro) Single / repeat dose toxicity studies + Bioanalysis / Toxicokinetics Safety Pharmacology Drug Metabolism Lead candidate Identified Clinical Non-clinical MOLECULE
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TOXICOKINETIC STUDIES ,[object Object],[object Object],[object Object],[object Object]
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[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],b) REPEATED DOSE STUDIES/SUB-ACUTE OR CHRONIC TOXICITY
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],Fertility and general reproductive performance study Segment II Teratogenicity Segment III Peri and post-natal study Fertility and early embryonic development (rat) Embryo- foetal development (rat & rabbit) Post natal development (rat) (post natal survival of offspring), growth parameters, vital senses, behavioral effects ,[object Object],[object Object],Implantation Embryogenesis
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[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],CONDUCT OF STUDY
EVALUATION OF RESULT ,[object Object],[object Object],[object Object],[object Object],[object Object]
 

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Animal toxicology studies

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  • 4. PHASES OF DRUG DEVELOPMENT (ANIMAL MAN) PHASE III PHASE IV PHASE I PHASE I PRECLINICAL PHASE II Product Approval (NDA/MAA) Patient studies Entry to man (IND / CTA) None Healthy subjects Safety and tolerability Genetic toxicity (in vivo) Repeat dose toxicity testing + Bioanalysis / Toxicokinetics Drug Metabolism Reproductive Toxicity Testing (teratogenicity) Patients Small scale efficacy studies Patients Large scale multicentre studies Chronic (long term) toxicity testing + Bioanalysis / Toxicokinetics Reproductive Toxicity Testing (fertility and pre/post natal) Carcinogenicity studies Drug Metabolism Patients Large scale post-marketing studies As required Genetic toxicity (in vitro) Single / repeat dose toxicity studies + Bioanalysis / Toxicokinetics Safety Pharmacology Drug Metabolism Lead candidate Identified Clinical Non-clinical MOLECULE
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