Clinical Trials of Drugs and Biopharmaceuticals  book cover
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Clinical Trials of Drugs and Biopharmaceuticals




ISBN 9780849321856
Published September 19, 2005 by CRC Press
520 Pages 11 B/W Illustrations

 
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Book 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.

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

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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