EMA: No biowaivers for NTIDs [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2020-07-15 21:08 (864 d 13:58 ago) – Posting: # 21704
Views: 2,370

Hi dshah,

❝ We are working on a NTI drug with high variability for which different dissolution media is recommended by USFDA.

❝ For BE study as per USFDA- a fasting and fed study for highest strength is recommended.


Why don’t you simply tell us that the drug is rivaroxaban? :-D

❝ For EMA- A fed study on highest strength and a fasting study on another mid strength is concluded based on guideline.


Fine. Though there is no product-specific guidance for rivaroxaban publishd by the EMA, most people would consider it an NTID indeed. Following the logic of other NTID-guidances that would mean acceptance limits of 80.00–125.00% for Cmax and 90.00–111.11% for AUC. In rare cases the limits of Cmax have to narrowed as well. Up to you to provide a justification.

❝ For waiver request for other strength we need acceptable in vitro dissolution testing of all strengths.


Biowaivers for NTIDs are not acceptable. BE-Guideline APPENDIX III:

Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index.


Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,417 posts in 4,692 threads, 1,596 registered users;
14 visitors (0 registered, 14 guests [including 9 identified bots]).
Forum time: 10:06 CET (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5