Newly prequalified Active Pharmaceutical Ingredient (API)
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Revised sample zinc acceptability study protocol available
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WHO Prequalification provides new advice on zinc.
Updated bioequivalence and biowaiver application documents
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Updated versions of the Bioequivalence Trial Information Form (BTIF) and the Application for a biowaiver: Biopharmaceutics Classification System (BCS) fo
New appendix added to Bioequivalence Trial Information (BTIF)
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An appendix has been added to the Bioequivalence Trial Information Form (BTIF).