Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

by Cato,Allen

• ISBN13: 9780824703141
• ISBN10: 0824703146
• Edition: 2nd
• Format: Hardcover
• Copyright: 2002-03-26
• Publisher: CRC Press

Summary

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.

Table of Contents

Preface	v
Contributors	xi
Current Challenges and Future Directions of Drug Development	1	(20)
Allen Cato
Lynda Sutton
Allen Cato III
Preclinical Drug Discovery and Development	21	(26)
David S. Duch
Robert M. Ferris
The IND Process for New Drug Products	47	(18)
David M. Cocchetto
Performance and Interpretation of Laboratory Tests	65	(14)
W. Leigh Thompson
Rocco L. Brunelle
Michael G. Wilson
Issues in Endpoint Selection	79	(14)
Karen D. Weiss
Jay Philip Siegel
Dix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 Days	93	(20)
W. Leigh Thompson
Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations	113	(14)
Allen Cato
Myron B. Peterson
Electronic Capture of Clinical Trial Information	127	(8)
Daniel C. Cato
David B. Thomas
Providing Patient Access to Promising Investigational Drugs	135	(14)
Peggy J. Berry
Allen Cato
Issues in the Review of Clinical Drug Trials by IRBs	149	(28)
Dale H. Cowan
Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts	177	(22)
Paul J. Reitemeier
Informed Consent in Clinical Trials: Emerging Issues	199	(22)
Cheryl K. Fiedler
H. Russell Searight
Orphan Drug Development: David and Goliath	221	(12)
Allen Cato
Susan L. Watts
Lynda Sutton
Marlene E. Haffner
Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality	233	(20)
Nelson S. Irey
How to Deal with a Sudden, Unexpected Death in Clinical Studies	253	(10)
Allen Cato
Lynda Sutton
Clinical Trial Material-The Fuel for Clinical Research	263	(18)
David F. Bernstein
The Role of Pharmacokinetics in Drug Development	281	(38)
Allen Cato III
Richard Granneman
Building an NDA/BLA	319	(24)
Diana E. Fordyce
Angela Cahill
International Planning of Drug Clinical Trials	343	(18)
David L. Horwitz
Uncertainty in Drug Development: Approval Success Rates for New Drugs	361	(18)
Joseph A. DiMasi
Contract Clinical Research: Value to In-House Drug Development	379	(12)
F. Richard Nichol
Package Inserts as Viewed by the Busy Private Practitioner	391	(12)
Jean M. Findlay
New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances	403	(10)
Louis A. Morris
Peter H. Rheinstein
The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer	413	(10)
Todd S. Keiller
Anatomy of Drug Withdrawals in the United States	423	(16)
Marion J. Finkel
Appendices: Routine Clinical Analyte Test Results	439	(12)
Index	451