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Current Pharmacology & Toxicology Guidlines For Pharmaceutical Industry

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Prof. Dr. Basavaraj Nanjwade
Prof. Dr. Basavaraj Nanjwade
EducationBusinessHealth & Medicine
1 of 43
CURRENT PHARMACOLOGY & TOXICOLOGY GUIDLINES FOR PHARMACEUTICAL INDUSTRY Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D Associate Professor Department of Pharmaceutics KLE University BELGAUM - 10 By
Objective of the Guidance ,[object Object],[object Object],[object Object]
Background ,[object Object]
Scope of Guidance ,[object Object],[object Object]
Safety Pharmacology ,[object Object]
Pharmacology Guidance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pharmacology Guidance ,[object Object],[object Object],[object Object],[object Object],[object Object]
Objective of Studies ,[object Object],[object Object],[object Object]
General Considerations in Selection and Design of Safety Pharmacology Studies ,[object Object],[object Object],[object Object],[object Object],[object Object]
General Considerations in Selection and Design of Safety Pharmacology Studies ,[object Object],[object Object]
Test Systems ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dose Levels or Concentrations of Test Substance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Duration of Studies ,[object Object],[object Object],[object Object],[object Object]
Studies on Metabolites, Isomers and Finished Products ,[object Object],[object Object],[object Object]
Safety Pharmacology Core Battery ,[object Object],[object Object],[object Object]
Follow-up and Supplemental Safety Pharmacology Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Conditions Under Which Studies Are Not Necessary ,[object Object],[object Object]
Conditions Under Which Studies Are Not Necessary ,[object Object],[object Object],[object Object]
Timing of Safety Pharmacology Studies in Relation to Clinical Development ,[object Object],[object Object],[object Object],[object Object]
Application of Good Laboratory Practice ,[object Object],[object Object],[object Object],[object Object]
TOXICOLOGY ,[object Object]
Recommended Toxicology Testing ,[object Object],[object Object],[object Object],[object Object],[object Object]
Recommended Toxicology Testing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Genetic toxicity tests ,[object Object],[object Object],[object Object]
Short-term toxicity studies with rodents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Short-term toxicity studies with rodents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Short-term toxicity studies with rodents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Short-term toxicity studies with rodents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Short-term toxicity studies with rodents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Chronic toxicity or Combined chronic toxicity/carcinogenicity studies with rodents ,[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]
Chronic toxicity or Combined chronic toxicity/carcinogenicity studies with rodents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reproduction studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reproduction studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reproduction studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reproduction studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reproduction studies ,[object Object],[object Object],[object Object],[object Object],[object Object]
Development toxicity studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Development toxicity studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metabolism and Pharmacokinetic studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metabolism and Pharmacokinetic studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Human studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Human studies ,[object Object],[object Object],[object Object],[object Object]
[object Object],E-mail: bknanjwade@yahoo.co.in

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  • 1. CURRENT PHARMACOLOGY & TOXICOLOGY GUIDLINES FOR PHARMACEUTICAL INDUSTRY Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D Associate Professor Department of Pharmaceutics KLE University BELGAUM - 10 By
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