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Guidance for industry analytical procedures and methods validation, chemistry, manufacturing, and controls documentation.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format: Government Document Online Book
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2000]
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Access:ONLINE VERSION
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