Clinical Research

A MEGA BOOK OF CLINICAL RESEARCH AND CLINICAL TRIALS New Drug DevelopmentPatent & ExclusivityTypes of Animal StudiesPre-clinical toxicity Studies - LD50Special Toxicity Studies - Carcinogenicity, Teratogenicity, Genotoxiciity, Reproductive toxicityPhases of Clinical ResearchICH-GCP - Principles & Guidelines- IRB/IEC, Sponsor, Investigator, SiteClinical Trial Design - Types & MethodsPharmacodynamicsPharmacokinetics BA, BE ( Bioavailability, Bioequivalence)Quality - QMS, QA, QCData Management - CDMPharmacovigilance Clinical Research & Clinical Trials