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

Designed for the practice of professional pharmacovigilance. MedDRA, FDA, EMEA, Eudravigilance, Regulatory framework submissions and timelines, GVP - 2012, Narrative Writing - Rules & Format, ARGUS, Signal Detection. Special Features. The Pharmacovigilance Interview: Can help you clear job interviews and start a career or get that better job. An exhaustive yet usable list of IME: Can help a professional differentiate between serious and non-serious cases and improve regulatory submission compliance.

The Oak has many secret doors and hidden tunnels. Anything that wants to enter it has to know the secret path or it could scurry the entire night and still keep running around in circles, ending up at the same place where it started. Ending up the same place you started. Ha Ha. That would make others laugh at you. Isn't it? Shadows play on the walls as the candle flames flicker in the light breeze that wafts through the open windows. In the center of the room is a hunched figure. The sight of the trickster swinging on a twig sends it into a tizzy. The belly of the drone has been put into...

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...