Clinical Trials of Drugs and Biopharmaceuticals: 1st Edition (Hardback) book cover

Clinical Trials of Drugs and Biopharmaceuticals

1st Edition

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

CRC Press

520 pages | 11 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9780849321856
pub: 2005-09-19
SAVE ~$60.00
$300.00
$240.00
x
eBook (VitalSource) : 9780429124198
pub: 2005-09-19
from $150.00


FREE Standard Shipping!

Description

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.

Reviews

“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

Table of Contents

Preparation for Clinical Trials

Drug Discovery and Preclinical Research, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee

The Pharmaceutical Background, S.C. Valvani

The Pharmacological Background for Drug Evaluation, L.H. Lee, C.L Wu, B.R. Lee, and C.-J. Lee

Animal Tests as Predictors of Human Response, P.I. Folb

Regulatory Organization and Decision Making

Worldwide Regulatory Agencies, C.-J. Lee, L.H. Lee, C.L.Wu, B.R. Lee, and M.-L. Chen

Decision Points in Drug Development, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Management of Clinical Development Costs, M. Hovde

Ethical Aspects and Good Clinical Practice, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Investigational New Drug Application and the Licensure Approval Process, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Clinical Trials from Phase I to Phase IV, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Evaluation anad Quality Assurance of Drugs and Biopharmaceuticals

The Assessment of Pharmacokinetics in Early-Phase Drug Evaluation, P.E. Rolan and V. Molnar

Drug Interactions, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Assessment of Cardiovascular Drugs

Antianginal Drugs, N.C. Pauly

Antihypertensive Drugs, W.S. Waring and D.J. Webb

Drugs for Treatment of Stroke, M. Soehngen, W. Soehngen, and Y. Al-Rawi

Assessment of Respiratory Drugs

Antiasthmatic Drugs, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Assessment of Central Nervous System Drugs

Anxiolytics and Hypnotics, G.R. McClelland and G. Moroz

Antidepressants, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Drugs for Alzheimer ’s Disease and Other Dementias, B.R. Lee, L.H. Lee, C.L. Wu, and C.-J. Lee

Assessmentof Gastrointestinal and Liver Drugs

Antiulcer Drugs, B.R. Lee, L.H. Lee, C.L. Wu, and C.-J. Lee

Assessment of Genitourinary Drugs

Diuretics, H.H. Shah, P.C. Singhal, and J. Mattana

Medical Therapy of Benign Prostatic Hyperplasia, B.R. Lee

Assessment of Skin Drugs

Drugs for the Treatment of Specific Skin Diseases, M.A. Haniffa, A.B. Alexandrov, S.N. Leech, and C.M. Lawrence

Drugs for the Treatment of Atopic Eczema, C.L. Wu, L.H. Lee, B.R. Lee, and C.-J. Lee

Assessment of Metabolism Drugs

Drugs for Treatment of Disorders of Lipid Metabolism, C.L. Wu, L.H. Lee, B.R. Lee, and C.-J. Lee

Antidiabetic Drugs, C.L. Wu, L.H. Lee, B.R. Lee, and C.-J. Lee

Assessment of Chemotherapeutic Drugs

Antibiotics, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Antiviral Drugs, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee

Anticancer Drugs, R.E. Martell, C. Langer, and R. Canetta

Assessment of Antiinflammatory and Pain Drugs

Analgesics, C.L. Wu, R.W. Hurley, and J.W. Stauffer

Assessment of Biopharmaceuticals

Vaccines, C.-J. Lee, L.H. Lee, C.L. Wu, B.R. Lee, and M.-L. Chen

Herbal Products as Complementary and Alternative Medicine, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee

Biotechnology-Derived Pharmaceuticals, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee

Future Perspective

Future Perspectives in Drug Development, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee

Future Perspectives in Biopharmaceutical Development, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee

Index

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy
SCI013000
SCIENCE / Chemistry / General