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Title Clinical trials of drugs and biopharmaceuticals / [edited by] Chi-Jen Lee [and others]
Published Boca Raton, FL : CRC Press/Taylor & Francis, 2006
Online access available from:
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Description 1 online resource (500 pages)
Contents Drug discovery and preclinical research / Chi-Jen Lee [and others] -- The pharmaceutical background / Shri C. Valvani -- The pharmacological background for drug evaluation / Lucia H. Lee [and others] -- Animal tests as predictors of human response / Peter I. Folb -- Worldwide regulatory agencies / Christopher L. Wu, Benjamin R. Lee, and Mei-Ling Chen -- Decision points in drug development / Lucia H. Lee [and others] -- Management of clinical development costs / Mark Hovde -- Ethical aspects and good clinical practice / Lucia H. Lee [and others] -- Investigational new drug application and the licensure approval process / Lucia H. Lee [and others] -- Clinical trials from Phase I to Phase IV / Lucia H. Lee [and others] -- The assessment of pharmacokinetics in early-phase drug evaluation / Paul E. rolan and Valaria Molnar
Drug interactions / Lucia H. Lee [and others] -- Antianginal drugs / Nancy C. Pauly and Edmond Roland -- Antihypertensive drugs / W. Stephen Waring and David J. Webb -- Drugs for treatment of stroke / Mariola Soehngen, Wolfgang Soehngen, and Yasir Al-Rawi -- Antiasthmatic drugs / Lucia H. Lee [and others] -- Anxiolytics and hypnotics / Graham R. McClelland and Georges Moroz -- Antidepressants / Lucia H. Lee [and others] -- Drugs for Alzheimer's disease and other dementias / Benjamin R. Lee [and others] -- Antiulcer drugs / Benjamin R. Lee [and others] -- Diuretics / Hitesh H. Shah, Pravin C. singhal, and Joseph Mattana -- Medical therapy of benign prostatic hyperplasia / Benjamin R. Lee
Drugs for the treatment of specific skin diseases / Muzlifah A. Haniffa [and others] -- Drugs for the treatment of atopic eczema / Christopher L. Wu [and others] -- Drugs for treatment of disorders of lipid metabolism / Christopher L. Wu [and others] -- Antidiabetic drugs / Christopher L. Wu [and others] -- Antibiotics / Lucia H. Lee [and others] -- Antiviral drugs / Lucia H. Lee [and others] -- Anticancer drugs / Robert E. Martell, Christiane Langer, and Renzo Canetta -- Analgesics / Christopher L. Wu, Robert W. Hurley, and Joseph W. Stauffer -- Vaccines / Chi-Jen Lee [and others] -- Herbal products as complementary and alternative medicine / Chi-Jen Lee [and others] -- Biotechnology-derived pharmaceuticals / Chi-Jen Lee [and others] -- Future perspectives in drug development / Christopher L. Wu, Benjamin R. Lee, and Mei-Ling Chen -- Future perspectives in biopharmaceutical development / Chi-Jen Lee [and others]
Summary 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
Notes Revised edition of: Handbook of phase I/II clinical drug trials. 1997
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Clinical trials.
Drugs -- Testing.
Drug Evaluation -- methods.
Biopharmaceutics -- methods.
Clinical Trials, Phase I as Topic -- methods.
Clinical Trials, Phase II as Topic -- methods.
Clinical Trials, Phase III as Topic -- methods.
Clinical Trials, Phase IV as Topic -- methods.
Form Electronic book
Author Lee, Chi-Jen.
ISBN 1420039148 (electronic bk.)
9781420039146 (electronic bk.)
(alk. paper)
(alk. paper)
OTHER TI Handbook of phase I/II clinical drug trials