Pharmaceutical Process Scale-Up edited by Michael Levin Metropolitan Computing Corporation East Hanover, New Jersey Marcel Dekker, Inc. TM New York • Basel Copyright ©…

Pharmaceutical Process Scale-Up DK5758_half-series-title.qxd8/16/0511:23 AMPage A DRUGS AND THE PHARMACEUTICAL SCIENCES Executive Editor James Swarbrick PharmaceuTech, Inc.…

1. Overview of Regulatory EnvironmentOverview of Regulatory Environment in USA, Europe & Indiain USA, Europe & India Dijo Mathew JohnDijo Mathew John Pharm.D…

DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs 1. Pharmacokinetics, Milo Gibaldi and Donald Perrier 2. Good Manufacturing Practices for Pharmaceuticals:…

Slide 1 Toxicology in Drug Development Lynnda Reid, Ph.D. Pharmacology/Toxicology Reviewer Center for Drug Evaluation and Research (CDER) Rafael Ponce, Ph.D., DABT Senior…

Slide 1 Regulatory Issues Slide 2 Introduction to the Regulatory Approval Process; Overview of the FDA Investigational New Drug Application (IND); Summary of regulations…

Pharmaceutical Stress Testing © 2005 by Taylor & Francis Group, LLC DRUGS AND THE PHARMACEUTICAL SCIENCES Executive Editor James Swarbrick PharmaceuTech, Inc. Pinehurst,…