ABSTRACT

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 de

chapter 1|20 pages

Current Challenges and Future Directions of Drug Development

ByAllen Cato, Lynda Sutton, and Allen Cato III

chapter 2|24 pages

Preclinical Drug Discovery and Development

ByDavid S. Duch, Robert M. Ferris

chapter 3|18 pages

The IND Process for New Drug Products

ByDavid M. Cocchetto

chapter 4|13 pages

Performance and Interpretation of Laboratory Tests

ByW. Leigh Thompson, Rocco L. Brunelle, Michael G. Wilson

chapter 5|13 pages

Issues in Endpoint Selection

ByKaren D. Weiss, Jay Philip Siegel

chapter 8|7 pages

Electronic Capture of Clinical Trial Information

ByDaniel C. Cato, David B. Thomas

chapter 9|12 pages

Providing Patient Access to Promising Investigational Drugs

ByPeggy J. Berry, Allen Cato

chapter 10|24 pages

Issues in the Review of Clinical Drug Trials by IRBs

ByDale H. Cowan

chapter 12|19 pages

Informed Consent in Clinical Trials: Emerging Issues

ByCheryl K. Fiedler, H. Russell Searight

chapter 13|11 pages

Orphan Drug Development: David and Goliath

ByAllen Cato, Susan L. Watts, Lynda Sutton, Marlene E. Haffner

chapter 15|9 pages

How to Deal with a Sudden, Unexpected Death in Clinical Studies

ByAllen Cato, Lynda Sutton

chapter 16|17 pages

Clinical Trial Material—The Fuel for Clinical Research

ByDavid F. Bernstein

chapter 17|34 pages

The Role of Pharmacokinetics in Drug Development

ByAllen Cato III and Richard Granneman

chapter 18|21 pages

Building an NDA/BLA

ByDiana E. Fordyce, Angela Cahill

chapter 19|16 pages

International Planning of Drug Clinical Trials

ByDavid L. Horwitz

chapter 20|19 pages

Uncertainty in Drug Development: Approval Success Rates for New Drugs

ByJoseph A.DiMasi

chapter 21|11 pages

Contract Clinical Research: Value to In-House Drug Development

ByF. Richard Nichol

chapter 22|11 pages

Package Inserts as Viewed by the Busy Private Practitioner

ByJean M. Findlay

chapter 25|13 pages

Anatomy of Drug Withdrawals in the United States

ByMarion J. Finkel