提交拟议的非活性成分 (IIG) 辅料含量控制函件时的注意事项-Williams-Greene.pdf

1、Considerations When Submitting Proposed Excipient Levels in Inactive Ingredient(IIG)Controlled CorrespondencesZakia R.Williams-Greene,PhDSenior PharmacologistDivision of Bioequivalence I,Office of Generic DrugsCDER|US FDAGeneric Drugs Forum(GDF)-April 09,2025fda.gov/cdersbiafda.gov/cdersbia2This pre

2、sentation reflects the views of the author and should not be construed to represent FDAs views or policies.DISCLAIMERfda.gov/cdersbiafda.gov/cdersbia3 To encourage focused correspondence per the dosing guidelines provided in the reference listed drug labeling.To explain how Maximum Daily Exposure(MD

3、E)levels are evaluated according to the respective Maximum Daily Dose(MDD)when based on the requested patients age and/or weight.Learning Objective fda.gov/cdersbiafda.gov/cdersbia4Evaluating proposed MDE excipient levels often presents a nuanced challenge.Comprehensive assessments of MDDs are based

4、 on patient age,body surface area,and weight.Introductionfda.gov/cdersbiafda.gov/cdersbia5 IIG CC inquiries for proposed MDE levels should align with:the reference listed drug labeling dosing instructions across patient populations,and the recommended three-evaluation limit in the Controlled Corresp

5、ondence Related to Generic Drug Development Guidance for Industry(March 2024)(CC Guidance).Introduction cont.fda.gov/cdersbiafda.gov/cdersbia6CC Guidance:Section IV.C.Additional Recommendations on the Content of Specific Types of Controlled Correspondence InquiriesIntroduction cont.fda.gov/cdersbiaf

6、da.gov/cdersbia7The following slides contain example case studies.Case studies fda.gov/cdersbiafda.gov/cdersbia8Prospective applicant Z inquired about three proposed MDE levels in the pediatric population with a body weight of 1 kg to less than 7 kg.The applicants proposed MDE levels were based on a