Chemistry, Manufacturing, and Controls in New Drug Applications
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Main description:
This title provides a useful how–to guide for practioners in the pharmaceutical industry who are navigating the FDA regulations for new drugs. Its coverage allows the user to develop the documentation needed to support changes before, during, and after the approval process, and provides recommended reporting categories. Topics such as documenting the drug substance, the drug product, analytical methodology, stability and methods of validation, container and closure systems, biologics, the drug master file, and scale–up and postapproval changes are addressed.
PRODUCT DETAILS
ISBN-13: 9780470077955
Publisher: John Wiley & Sons Ltd (Wiley–Blackwell)
Publication date: February, 2018
Pages: 380
Weight: 652g
Availability: Not available (reason unspecified)
Subcategories:
Publisher: John Wiley & Sons Ltd (Wiley–Blackwell)
Publication date: February, 2018
Pages: 380
Weight: 652g
Availability: Not available (reason unspecified)
Subcategories:
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