Böcker av Ravi N Humbarwadi

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

Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoepidemiology: Study Designs - Types of designs and their use in different situations. Comprehensive description of NIS. Protocol, STROBE, ENCePP and Good pharmacoepidemiology Practices.Pharmacovigilance Database: Graphic Description. Field by Filed and Module by Module. Includes Overview of Oracle ARGUS. A MEGA BOOK OF DRUG SAFETY. Clear Any Interview. Get That Better Job.