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Phase II Proof Of Concept Study Design Options For Co-developed Drugs

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FDA Draft Co-Development Guidance Emphasizes Phase II Studies

Clinical trial strategies proposed in FDA's draft guidance for co-development of drugs designed for use in combination in most cases whittle the design down to standard of care versus the combination before Phase III, offering the prospect of cutting not only development time but also clinical trial costs.

FDA Draft Co-Development Guidance Emphasizes Phase II Studies

Clinical trial strategies proposed in FDA's draft guidance for co-development of drugs designed for use in combination in most cases whittle the design down to standard of care versus the combination before Phase III, offering the prospect of cutting not only development time but also clinical trial costs.

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