Bioequivalence and Bioavailability Forum 09:30 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Highly Variable Drug BE Justification [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-03-20 04:42  - Posting: # 17166
Views: 16,383

(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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,914 posts in 4,036 threads, 1,283 registered users;
online 24 (0 registered, 24 guests [including 18 identified bots]).

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed