2nd Edition

Clinical Drug Trials and Tribulations, Revised and Expanded

By Allen Cato, Lynda Sutton, Allen Cato III Copyright 2002

    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.
  • 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


    Allen Cato, Allen Sutton, Allen Cato III

    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