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increases insulin secretion) in response to eating meals
ICH M13B is a draft Step 2b guidance (endorsed 13 March 2025) that complements the main ICH M13A -Bioequivalence for Immediate release solid oral dosage forms by providing in-vitro study recommendations for additional strength biowaivers
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However, for many years these suggestions were ignored, until the development of radioimmunoassays, when Elrich et al
