Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 1, 1990 - Issue 2
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Original Articles

Elements of a quality assurance program for pharmaceutical research & developmentFootnote1

Pages 129-136 | Published online: 11 Jun 2008

References

  • Biesterfeld , C. H. 1949 . Patent Law for Lawyers, Students, Chemists and Engineers , (2nd Edition) , New York : John Wiley .
  • Food and Drug Administration . 1987 . Guideline for the Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application , Rockville : Food and Drug Administration .
  • Juran , J. M. 1974 . “ Basic Concepts ” . In Quality Control Handbook , (3rd Edition) , Edited by: Juran , J. M. , Gryna , F. M. Jr. and Bingham , R. S. Jr. New York : McGraw‐Hill .
  • Kitch , E. W. 1973 . “ The Patent System and the New Drug Application: an Evaluation of the Incentives for Private Investment in New Drug Research and Marketing ” . In Regulating New Drugs , Edited by: Landau , R. L. Chicago : University of Chicago Center for Public Policy .
  • Maynard , J. T. 1978 . Understanding Chemical Patents a Guide for the Inventor , Washington, D.C. : American Chemical Society .
  • Office of the Federal Register . 1988 . Code of Federal Regulations, Title 21 , Washington, D.C. : General Services Administration .
  • 1983 . PMA Guidelines for the Preparation and Control of Clinical Supplies , Washington, D.C. : Pharmaceutical Manufacturer's Association .
  • 1982 . PMA Position Paper , The Role of the LD50 Determination in Drug Safety Evaluation Washington, D.C. : Pharmaceutical Manufacturers Association .
  • Young , F. 1987 . Strengthening the FDA Through Stability, Modernization, and Statemanship , Washington, D.C. : Speech to Food and Drug Law Institute .
  • I wish to thank Dr. John Donahue, Vice‐President, Worldwide Regulatory Compliance, SmithKline Beckman Corporation, for his many helpful comments, suggestions, and editorial services.

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