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Good Laboratory Practice for Nonclinical Studies
Engelsk
Bogcover for Good Laboratory Practice for Nonclinical Studies af , 9781032381152
Specifikationer
Sprog:
Engelsk
Sider:
194
ISBN-13:
9781032381152
Indbinding:
Paperback
ISBN-10:
1032381159
Udg. Dato:
9 okt 2024
Størrelse i cm:
23,4 x 15,6
Oplagsdato:
9 okt 2024

Good Laboratory Practice for Nonclinical Studies

Engelsk
Paperback 2024
Format:

Bog beskrivelse

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.

• Unique volume covering FDA inspections of GLP facilities

• Provides a detailed interpretation of GLP Regulations

• Presents the latest on electronic data management in GLP

• Describes GLP and computer systems validation

• Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

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Specifikationer
Sprog:
Engelsk
Sider:
194
ISBN-13:
9781032381152
Indbinding:
Paperback
ISBN-10:
1032381159
Udg. Dato:
9 okt 2024
Størrelse i cm:
23,4 x 15,6
Oplagsdato:
9 okt 2024
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