by Iftekhar Mahmood
Pine House Publishers
Rockville, MD, USA

2006 by Pine House Publishers
586 pages

ISBN  0-9766438-1-2 (hard cover)

Price:  $180
Shipping:  $5 in US, $15 outside US

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From the Back Cover --

Clinical Pharmacology of Therapeutic Proteins is the first comprehensive book that covers the fundamentals of clinical pharmacology aspects of protein drugs and monoclonal antibodies.

The book:

  • Provides readers with a practical view of pharmacokinetics and pharmacodynamics and their usefulness in drug development.

  • Discusses analytical methods for pharmacokinetic studies of therapeutic proteins and unique challenges in detecting these drugs in biological fluids.

  • Focuses on the important differences between the conventional drugs and biotech products during the discovery and development.

  • Discusses the immunogenicity issues and its impact on the PK, safety, and efficacy of biologic products.

  • Describes the methods of PK allometric scaling from laboratory animals to humans and offers several approaches for the selection of the first-in-man dose based on predicted PK parameters.

  • Highlights the impact of important variables such as age, size, gender, race, concomitant drug administration, disease state, and genetic background on the PK and PD of protein drugs.

This book is an ideal resource for pharmaceutical scientists, clinical pharmacologists, toxicologists, and molecular biologists. This book can also serve as a text book for graduate students in schools of pharmacy and health sciences who want to get involved in the discovery and development of biologic products.

About the Author:

Iftekhar Mahmood, PhD, is a senior clinical Pharmacologist at the Center forDrug Evaluation and Research (CDER, FDA. He holds a Bachelor of Pharmacy degree and a Ph.D. degree in Pharmaceutical Sciences with specialization
in pharmacokinetics. Dr. Mahmood joined the FDA in December 1993 and for more than eight years served as a clinical pharmacologist dealing with neuropharmacological products. Since the last 4 years, Dr. Mahmood has been a clinical pharmacologist for therapeutic proteins. His research interests include interspecies scaling, limited sampling and Bayesian approach in pharmacokinetics, population pharmacokinetics and pharmacodynamics, and absorption kinetics. Dr.Mahmood has published more than 60 scientific papers in peer-reviewed scientificjournals. Dr. Mahmood is the recipient of several CDER Intramural ResearchGrants as well as the recipient of several CDER and CBER awards.



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