Clinical drug trials and tribulations

著者

書誌事項

Clinical drug trials and tribulations

edited by Allen Cato, Lynda Sutton, Allen Cato III

（Drugs and the pharmaceutical sciences, v. 120）

Marcel Dekker, c2002

2nd ed., rev. and expanded

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注記

Includes bibliographical references and index

HTTP:URL=http://www.loc.gov/catdir/toc/fy035/2002019336.html Information=Table of contents

内容説明・目次

内容説明

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

目次

Current Challenges and Future Directions of Drug Development Allen Cato, Lynda Sutton, and Allen Cato III Preclinical Drug Discovery and Development David S. Duch and Robert M. Ferris The IND Process for New Drug Products David M. Cocchetto Performance and Interpretation of Laboratory Tests W. Leigh Thompson, Rocco L. Brunelle, and Michael G. Wilson Issues in Endpoint Selection Karen D. Weiss and Jay Philip Siegel Dix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 Days W. Leigh Thompson Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations Allen Cato and Myron B. Peterson Electronic Capture of Clinical Trial Information Daniel C. Cato and David B. Thomas Providing Patient Access to Promising Investigational Drugs Peggy J. Berry and Allen Cato Issues in the Review of Clinical Drug Trials by IRBs Dale H. Cowan Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts Paul J. Reitemeier Informed Consent in Clinical Trials: Emerging Issues Cheryl K. Fiedler and H. Russell Searight Orphan Drug Development: David and Goliath Allen Cato, Susan L. Watts, Lynda Sutton, and Marlene E. Haffner Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality Nelson S. Irey How to Deal with a Sudden, Unexpected Death in Clinical Studies Allen Cato and Lynda Sutton Clinical Trial Material-The Fuel for Clinical Research David F. Bernstein The Role of Pharmacokinetics in Drug Development Allen Cato III and Richard Granneman Building an NDA/BLA Diana E. Fordyce and Angela Cahill International Planning of Drug Clinical Trials David L. Horwitz Uncertainty in Drug Development: Approval Success Rates for New Drugs Joseph A. DiMasi Contract Clinical Research: Value to In-House Drug Development F. Richard Nichol Package Inserts as Viewed by the Busy Private Practitioner Jean M. Findlay New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances Louis A. Morris and Peter H. Rheinstein The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer Todd S. Keiller Anatomy of Drug Withdrawals in the United States Marion J. Finkel Appendices: Routine Clinical Analyte Test Results Index

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