CLINICAL PHARMACOLOGY OF
Pine House Publishers
Rockville, MD, USA
2006 by Pine House Publishers
0-9766438-1-2 (hard cover)
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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.
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
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.