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01/01/1990
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CMC Regulatory Strategy: Planning Chemistry, Manufacturing and Controls for ApprovalClinical data gets most of the attention in drug development, but the Chemistry, Manufacturing and Controls (CMC) section of a filing is where many programs run into trouble. Regulators need confidence that the product can be made consistently, tested reliably, and supplied without compromising quality. A clear CMC regulatory strategy helps a development team build that case step by step...0 Комментарии 0 Поделились 53 Просмотры 0 предпросмотрВойдите, чтобы отмечать, делиться и комментировать!
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