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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

J Biol Chem 267: 74027405, 1992

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This gap exists partly because the research peptide market operates with minimal regulatory oversight

Sharps bins: Used needles and pen devices should be placed in an approved sharps container (yellow-lidded bin)