Clinical Drug Trials and Tribulations, Revised and Expanded

ISBN-13: 9780824703141 / Angielski / Twarda / 2002 / 368 str.

Cato; Allen E. Cato; Lynda Sutton

Opis

This title comprehensibly addresses the day-to-day challenges of drug development with a contemporary assessment of the areas affecting the conduction of non-clinical and clinical studies.

Recenzje

"
Praise for the first edition…

…serves well as a discussion of the clinical drug development process…will be of great value to anyone involved in regulatory affairs, clinical research, or pharmaceutical development.
"-Journal of Pharmaceutical Sciences

Spis treści

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

O autorze

Allen Cato, Allen Sutton, Allen Cato III