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Medical Protocols Government Policy United States
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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

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:P 94/2    ---  Available
2
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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

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:IN 2/2    ---  Available
3
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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

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Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:ST 1    ---  Available
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