Good laboratory practice regulations
著者
書誌事項
Good laboratory practice regulations
（Drugs and the pharmaceutical sciences, v. 124）
M. Dekker, c2003
3rd ed., rev. and expanded
大学図書館所蔵 全3件
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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