Description
A MEGA BOOK OF CLINICAL RESEARCH AND CLINICAL TRIALS New Drug Development Patent & Exclusivity Types of Animal Studies Pre-clinical toxicity Studies – LD50 Special Toxicity Studies – Carcinogenicity, Teratogenicity, Genotoxiciity, Reproductive toxicity Phases of Clinical Research ICH-GCP – Principles & Guidelines- IRB/IEC, Sponsor, Investigator, Site Clinical Trial Design – Types & Methods Pharmacodynamics Pharmacokinetics BA, BE ( Bioavailability, Bioequivalence) Quality – QMS, QA, QC Data Management – CDM Pharmacovigilance Clinical Research & Clinical Trials
