[PDF] [PDF] M9 Step 5 on biopharmaceutics classification system based

10 fév 2020 · Eligibility of a drug product for a BCS based biowaiver 9 3 1 moderate (5–20 ; Peng et al , Eur J Pharm Sci (56), 2014; Jin et al a wider excipient risk assessment, for example sensitivity analysis using an EMA/ CHMP/ICH/10044/2020 Page 18/22 S ectio n s o f IC H M9 Gu id elin



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