Handbook of Phase I/II Clinical Drug Trials / Edition 1

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Designing a drug development program or key study can be a daunting task due to growing limitations on time and resources in industry and in academia. Scientific advances and increasing competition in the drug development arena demand a quick, easy-to-use source of data. The Handbook of Phase I/II Clinical Drug Trials is that source. It is an indispensable guide, readily providing the information needed to make crucial decisions regarding drug therapies. This book makes it easy to plan cost-effective, early drug development programs.

The first four sections of the text deal with the preliminaries to studying drugs in humans, as well as considerations common to early drug trials in human subjects. Part II considers organization and decision making factors. Ethical and legal considerations are discussed in the next section. Subsequent chapters deal with specific therapeutic areas and indications. Areas of growing importance, such as studying in vitro metabolism in human hepatocytes and genetic engineering are highlighted as well. The Handbook of Phase I/II Clinical Drug Trials is your complete guide to successful early drug development.

The book contains black-and-white illustrations.

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Editorial Reviews

A guide to planning cost-effective, early drug development programs, with sections on preliminaries for testing, organization and decision making, ethical and legal consideration, measuring drug activity in humans, and assessing drug effects on various body systems. This second edition of the previously titled "Early Phase Drug Evaluation in Man" contains new chapters on "in vitro" metabolism in human hepatocytes, genetic engineering, and biotechnology products. Of interest to pharmaceutical scientists and researchers, clinical pharmacologists, toxicologists, immunologists, and dermatologists. Annotation c. by Book News, Inc., Portland, Or.
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Product Details

  • ISBN-13: 9780849392306
  • Publisher: Taylor & Francis
  • Publication date: 1/14/1997
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 576
  • Product dimensions: 7.00 (w) x 10.10 (h) x 1.40 (d)

Table of Contents

Preliminaries to Testing in Humans The Pharmaceutical Background, S.C. Valvani The Pharmacological Background, B.J.R. Whittle, J.A. Salmon, and R.M. Ferris The Metabolic Background, W.J. Adams Animal Tests as Predictors of Human Response, D. Wood and P.I. Folb The In Vitro Assessment of Human Hepatic Drug Metabolism, G.T. Tucker Organization and Decision Making Decision Points in Human Drug Development, S.B. Reele Principles in Costing and Administration, M. Hovde Biotechnology, P. Harris Ethical and Legal Considerations Healthy Volunteers, S.J. Warrington Bioethics and Industry: Ethical Aspects of Research in Patients, F. WelIs Legal Liability in Clinical Trials, I.C. Dodds-Smith Measuring Drug Activity in Humans Study Design and Assessment of Wanted and Unwanted Drug Effects in Phase I/II Trials, M. Thomas The Assessment of Pharmacokinetics in Early Phase Drug Evaluation, P.E. Rolan Assessment of Drug Effects on the Cardiovascular System Non-Invasive Measurement of Cardiovascular Response, K.M. Donaldson and J. D. Harry Anti-Anginal Drugs, N. Pauly and E. Roland Anti-Arrhythmic Agents, P.K. Marrott Antihypertensive Drugs, K.P.J. O'Kane and D.J. Webb Drugs for Heart Failure, G.G. Belz and P.H. Joubert Peripheral Arterial Disease, J.J.F. Belch and W. Söhngen Assessment of Drug Effects on the Respiratory System Anti-Asthmatic Drugs, A.M. Edwards Assessment of Drug Effects on the CNS Measurement of CNS Effects. F. Kelly and J.R. Bratty Antiepileptic Drugs, J. Mercer and G. Hosking Anxiolytics and Hypnotics, G.R. McClelland Antidepressants, J. Dingemanse Antipsychotic Agents, C.G.G. Link and C.G. Jones Alzheimer's Disease and Other Dementias, R.L. Holland and K.A. Wesnes Antiparkinsonian Agents, J.L. Montastruc, O. Rascol, J.M. Senard, O. Blin, and C. Thalamas Assessment of Drug Effects on the Gastro-Intestinal System Gastro-Intestinal Effects, K.H. Antonin and P.R. Biek Anti-Ulcer Drugs, C. Broom Assessment of Drug Effects on the Genito-Urinary System Diuretics, J. McMurray and J. McEwen Renal Side Effects, A. Dawnay Assessment of Drug Activity in the Skin Measurement of Skin Response to Drugs, S. Shuster, P.M. Farr, and C.M. Lawrence Drugs for Eczema, J.R. Gibson and V.K. Manna Assessment of Drugs Used for the Treatment of Metabolic Disorders Phase II Trials with Lipid-Acting Drugs, C.A. Dujovne, P.E. Krehbiel, W.S. Harris, and S.J. Held Development of Antidiabetic Therapy Phases I and II, J.R. Bratty and F. Kelly Assessment of the Effects of Chemotherapeutic Agents Antibiotic Development, A. Bryskier Antiviral Drugs, W. Soo Anticancer Drugs, L.P. Schachter, M. Birkhofer, S. Carter, R. Canetta, S. Hellmann, N. Onetto, C. Weil, B. Winograd, and M. Rozencweig Assessment of Drugs Affecting the Inflammatory Process and Pain Analgesics, R.L. Holland Index

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