Clinical Drug Trials and Tribulations, Revised and Expanded: 2nd Edition (Hardback) book cover

Clinical Drug Trials and Tribulations, Revised and Expanded

2nd Edition

By Allen Cato, Lynda Sutton, Allen Cato III

CRC Press

368 pages

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pub: 2002-03-26
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Description

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.

  • Reviews

    "

    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

    Table of Contents

    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

    Subject Categories

    BISAC Subject Codes/Headings:
    MED071000
    MEDICAL / Pharmacology
    SCI013000
    SCIENCE / Chemistry / General