Good laboratory practice regulations
著者
書誌事項
Good laboratory practice regulations
（Drugs and the pharmaceutical sciences, v. 69）
Marcel Dekker, 1995
2nd ed., rev. and expanded
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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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