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Drug substances specifications, biotechnological

Biotechnological/Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Notice Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice... [Pg.76]

Guideline Q6A—Specifications for New Drug Substances and Products Chemical Substances Guideline Q6B—Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Other Quality Guidelines Relevant to Setting Specifications... [Pg.387]

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