Good Laboratory Practice Regulations, Second Edition
Seiten
1995
|
2nd New edition
Marcel Dekker Inc (Verlag)
978-0-8247-9377-7 (ISBN)
Marcel Dekker Inc (Verlag)
978-0-8247-9377-7 (ISBN)
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This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice regulations and techniques for implementation. This edition includes general knowledge on computer system validation and details on implementing GIPs in an automated laboratory.
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.
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.
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.
Erscheint lt. Verlag | 9.6.1995 |
---|---|
Reihe/Serie | Drugs and the Pharmaceutical Sciences |
Verlagsort | New York |
Sprache | englisch |
Themenwelt | Naturwissenschaften |
Technik | |
ISBN-10 | 0-8247-9377-3 / 0824793773 |
ISBN-13 | 978-0-8247-9377-7 / 9780824793777 |
Zustand | Neuware |
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