Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-21 03:01 CEST (UTC+2h)

Patient population for bioequivalence study [Regulatives / Guidelines]

posted by pash413 - India, 2017-10-04 15:44  - Posting: # 17855
Views: 550

Dear All
We are planning to conduct a bioequivalence study in patient population for USFDA submission.

As per product label, the drug is used in three indications (i.e. diseases)

Out of three indication, patients comprise of two indication are difficult to recruit, because of disease criticality & severity. However for third indication, patients are abundantly available for the enrollment in to the BE study.

Considering the above fact, is it necessary to conduct bioequivalence study in all eligible patient population as per label or we can recruit only patients for third indication. Will there be any regulatory concerns in term of BE acceptance, product approval & getting marketing authorization for all indication.

Kindly share your view.

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,396 Posts in 3,726 Threads, 1,074 registered users;
25 users online (0 registered, 25 guests).

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

BEBAC Ing. Helmut Schütz