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Guidance for industry comparability protocols, protein drug products and biological products; chemis

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2003] 2003

Guidance for industry independent consultants for biotechnology clinical trial protocols.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [2004] 2004

Guidance for industry testing limits in stability protocols for standardized grass pollen extracts.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2000] 2000