This 2nd Edition of PDD is one the best bestsellers that one can get online for regulatory aspects of preclinical formulation and routes of administration. Importantly, this book covers A – Z’s of the latest pharmaceutical industry trends and compliance guidelines. Which are essential for every bench scientists to succeed.
Key benefits include
- expert contributorship— 16 internationally recognized authorities in the field deliver the latest research findings and industry trends, providing must-have guidance every scientist needs to succeed
- registration requirements — preclinical guidelines from the International Conference on Harmonization—enable experienced scientists and those new to the field, to remain compliant throughout the drug development process
- preclinical data — examines how animal testing data can improve a scientist’s ability to predict drug toxicity and estimate first-time doses in humans, consequently reducing the chance for error and saving time and money
- full-color illustrations — as well as an abundance of tables, charts, and diagrams, enhance the visual understanding of key topics such as safety assessment, making this source an accessible ready reference for all pharmaceutical industry personnel
- Taken from Informa Healthcare Books
Contents
- The Scope of Preclinical Drug Development: An Introduction and Framework
- Lead Molecule Selection – Pharmaceutical and Toxicity Assessments
- Interspecies Differences in Physiology and Pharmacology: Extrapolating Preclinical Data to Human Populations
- Pharmacokinetics/ADME of Small Molecules
- Pharmacokinetics/ADME of Large Molecules
- Preclinical Pharmacokinetic-Pharmacodynamic Modeling and Simulation in Drug Development
- Formulation and Route of Administration-In?uencing Drug Permeability and Absorption
- Assessment of Pharmacokinetics and Drug Activity: Isolated Organ Systems and the Membrane Transporter Family
- Toxicity Evaluations: ICH Guidelines and Current Practice
- Application of Pathology in Safety Assessment
- Utilizing the Preclinical Database to Support Clinical Drug Development
Author Information:
Mark C. Rogge
Senior Director, Development Pharmacokinetics & Disposition, Biogen Idec Corporation, Cambridge, Massachusetts, USA. Dr. Rogge received his Ph.D. in Pharmacy from the University of Michigan, Ann Arbor, Michigan, USA. He is the author of numerous professional publications and has given many presentations at scientific meetings, regulatory agencies, and universities. Dr. Rogge has served as Chair of the Pharmacokinetics, Pharmacodynamics and Drug Metabolism Section of the American Society of Pharmaceutical Scientists and now serves on the United States Pharmacopeia panel responsible for exploring scientific aspects of biotechnology products. He is member of the Biotechnology Industry Organization’s expert preclinical safety advisory group and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. Dr. Rogge is also Co-Editor of the first edition of Preclinical Drug Development
David R. Taft
/> Director and Associate Professor, the Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, New York, USA. Dr. Taft received his Ph.D. in Pharmaceutical Science from the University of Connecticut, School of Pharmacy, Storrs, Connecticut, USA. He is a member of the American Association of Pharmaceutical Scientists and the American Association of Colleges of Pharmacy, and serves on the editorial boards of several journals, including the Journal of Pharmaceutical Sciences, Drug Develoment and Industrial Pharmacy, Current Drug Discovery Technologies, and Informa Healthcare’s Current Medical Research and Opinion. Dr. Taft is also Co-Editor of the first edition of Preclinical Drug Development.
- Content and Author Information also taken from Informa Healthcare Books.
Informa Healthcare Books | cost: $350
Amazon | cost: $303.34 (Save 13%)
