Good laboratory practice regulations

著者
    • Weinberg, Sandy
書誌事項

Good laboratory practice regulations

edited by Sandy Weinberg

(Drugs and the pharmaceutical sciences, v. 69)

Marcel Dekker, 1995

2nd ed., rev. and expanded

この図書・雑誌をさがす
注記

Previous ed. edited by Allen F. Hirsch

Includes bibliographical references and index

内容説明・目次

内容説明

This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.

目次

  • Historical perspective
  • FDA/GLP regulations
  • EPA and foreign country GLP regulations
  • implementing GLPs in a non-GLP analytic laboratory
  • GLPs in an automated laboratory
  • computer system validation
  • the FDA's GLP inspection programme
  • the GLPs - the cybernetic necessity.

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