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Guidance for industry Q5E comparability of biotechnological/biological products subject to changes i

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] 2005

Guidance for industry Q9 quality risk management.

[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, [2006] 2006