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Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.

Bibliographic Details
Corporate Authors:	Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
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, [2005]
Subjects:	Biotechnological process monitoring. Pharmaceutical biotechnology. Biological products. International Conference on Harmonisation.
Online Access:	https://purl.fdlp.gov/GPO/LPS113768

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