Clinical Trials of Drugs and Biopharmaceuticals / Edition 1

by Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen

Overview

The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an intimate understanding of the mechanisms of pharmacokinetic and pharmacodynamic activity and the processes of drug evaluation is essential.

Clinical Trials of Drugs and Biopharmaceuticals provides an overview of current procedures and major issues involved in drug and biopharmaceutical development. The book examines critical biochemical and pharmaceutical considerations for trials conducted during each phase of clinical development. It also reports information related to early pre-clinical evaluations of pharmacological activities and safety before proceeding with initiation of clinical trials. The sections focus on clinical assessments of drugs and biopharmaceuticals such as cardiovascular, respiratory, central nervous system, gastrointestinal and liver, genitourinary, skin, metabolism, and chemotherapeutic drugs as well as vaccines, biotechnology-derived therapeutics, and plant-based medicines.

Practical and informative, this step-by-step guide includes information on all four phases of clinical trials prior to licensure and covers the design of post-marketing studies. The editors examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and approved.

Product Details

ISBN-13:	9780849321856
Publisher:	Taylor & Francis
Publication date:	09/19/2005
Edition description:	Revised ed.
Pages:	518
Product dimensions:	7.00(w) x 10.00(h) x (d)

About the Author

Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen

Table of Contents

Preparation for Clinical Trials. Regulatory Organization and Decision Making. Evaluation and Quality Assurance of Drugs and Biopharmaceuticals. Future Perspectives in Drug Development

Editorial Reviews

Reviewer: Alan Poisner, MD (University of Kansas Medical Center)
Description: This is a revised and expanded version of the Handbook of Phase I/II Clinical Drug Trials, by O'Grady and Joubert (CRC Press, 1997). This update is necessary because of changes in regulations and scientific knowledge in bringing drugs to market. The first 30 percent of the book deals with general themes and the rest deals with specific clinical areas.
Purpose: The purpose is to highlight critical chemical and biological considerations for drug development and all phases of clinical trials. The book provides an overview of current procedures and issues in this field and examines current challenges to future progress. These are worthy goals in a complicated regulatory environment. The objectives are met within the constraints of reasonable size for this task.
Audience: The authors indicate that the book is addressed to pharmaceutical and biopharmaceutical company professionals, university scientists, ministries of health and health authorities. Because of the breadth of potential readership, there is something for each of these groups, but some material will be outside each group's particular interests. Parts of it could also be useful to students in biomedical sciences. The authors are of diverse backgrounds and have extensive experience in their respective fields.
Features: The first part of the book provides background information on the preclinical background to clinical trials, chemical, pharmaceutical and biological. The next sections detail the scientific, legal, and ethical considerations involved in drug development. Two brief chapters on pharmacokinetics and drug interactions are useful for the scientist. The bulk of the book deals with specific details of studies in 21 different clinical areas. The chapters on Decision Points in Drug Development and Management of Clinical Development Costs are particularly good. It is useful to see in one place the various hurdles and potential solutions to the drug development process. Some of the chapters seem to have older references, but most are current to 2003-2004. Because of the breadth of the material, most readers will probably concentrate on some but all of the chapters.
Assessment: This book is useful because it consolidates information from preclinical and clinical fields and also adds the perspective of regulatory agencies in bringing drugs to market. Some chapters are quite short and there are multiple authors. This causes the usual variations in quality, style, and currency, but it does not detract from its overall usefulness. It definitely is more ambitious than the previous edition (which had a different name and more focused topic). It is also much more up to date.

Doody's Review Service

This book is useful because it consolidates information from preclinical and clinical fields and also adds the perspective of regulatory agencies in bringing drugs to market…definitely is more ambitious than the previous edition.”
—Alan Poisner, M.D., Doody’s Book Review Service
“This volume provides an overview of current procedures and major issues involved in drug and biopharmaceutical development. The book examines critical biochemical and pharmaceutical considerations for trials conducted during each phase of clinical development. It also reports information related to early pre-clinical evaluations of pharmacological activities and safety before proceeding with the initiation of clinical trials. … Practical and informative, this step-by-step guide includes information on all four phases of clinical trials prior to licensure and covers the design of post-marketing studies. The editors examine how recent advances and increased demand for safer and more effective drugs have changed the process by which drugs are developed and approved.”
— In Anticancer Research, Vol. 26, 2006

From the Publisher

3 Stars from Doody