With regards to the eligibility of additional strength biowaiver in Item 3 of dissolution profile comparisons documentation from PK section on the ANDA Refuse to File (RTF) checklist, what document is this item exactly check for?

刊登日期:2023-09-17  |  點閱次數 : 346 次 

This item is for confirmation whether the proposed drug product is eligible for additional strength biowaiver which defined in MOHW no. 0980364804 announcement. Take immediate-release products for example, if an in vivo BE study was conducted at lower strength, higher strength can request for biowaiver when the formulation are proportionally similar to in vivo BE batch and linear pharmacokinetic properties has been documented over the therapeutic dose range.



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