Allen Cato, Allen Sutton, Allen Cato III

Clinical Drug Trials and Tribulations, Revised and Expanded (eBook, PDF)

• Format: PDF

Produktbeschreibung

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

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 368
• Erscheinungstermin: 26. März 2002
• Englisch
• ISBN-13: 9780203909560
• Artikelnr.: 38172422

Autorenporträt

Allen Cato, Allen Sutton, Allen Cato III

Inhaltsangabe

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