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Back to the forum  2018-06-20 07:59 CEST (UTC+2h)

Highly Variable Drug BE Justification [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-03-20 04:42  - Posting: # 17166
Views: 8,830

(edited by jag009 on 2017-03-20 05:22)

Hi all,

Just want to know what your experience is on this matter.

The FDA stated that "Special Considerations: Applicants may consider using a reference-scaled average bioequivalence approach for x drug. If using this approach, the applicant should provide evidence of high variability (i.e., within-subject variability ≥30%) in bioequivalence parameters. Applicants who would like to use this approach are encouraged to submit a protocol for review by the Division of Bioequivalence in the Office of Generic Drugs."

The above implies that one can conduct replicate studies (RSABE) if he/she has supportive data (ISCV>=30%). What if one conducted pilot studies and found that the ISCV is like 28/29%? My concensus still would be to proceed with RSABE approach since the it is a mixed approach which allows both RSABE (if Ref SD<0.294) and ABE analysis (if Ref SD>0.294)

John

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