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Concerns and Expectations Regarding Stability Assessment with Modeling-Type Extrapolation in Biological Products, as Pertains to Revisions of ICH Q1/Q5C Guidelines

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Speaker Presentation Kameda Takashi PMDA 2023
Concerns and Expectations Regarding Stability Assessment with Modeling-Type Extrapolation in Biological Products, as Pertains to Revisions of ICH Q1/Q5C Guidelines

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