Good laboratory practice regulations

著者

    • Weinberg, Sandy, b. 1950

書誌事項

Good laboratory practice regulations

edited by Sandy Weinberg

（Drugs and the pharmaceutical sciences, v. 124）

M. Dekker, c2003

3rd ed., rev. and expanded

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注記

Bibliography: p. 229-237

Includes index

内容説明・目次

内容説明

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

目次

Historical Perspective, Jean M. Taylor and Gary C. Stein FDA/ GLP Regulations, Wendell A. Peterson Applying 21 CFR Part 11 to the Laboratory Environment, Sandy Weinberg The Good Automated Laboratory Practices, Gerald J. Whartenby, Paul L. Robinson, and Sandy Weinberg Implementing GLP's in a Non-GLP Analytical Laboratory, Stephanie A. Olexa Computer Systems Validation, Sandy Weinberg The FDA's GLP Inspection Program, George W. James The Future, Sandy Weinberg Bibliography Index

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