Ulteriori informazioni
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.
Sommario
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
Info autore
Allen Cato, Allen Sutton, Allen Cato III
Riassunto
Addresses the challenges of drug development with assessments of the areas affecting the conduction of non-clinical and clinical studies. This book also addresses which decisions should be made during drug development. It guides readers through the trials and tribulations that emerge and are pertinent to drug management.
