Not using Bio­strength for BE [Regulatives / Guidelines]

posted by zheng791 – US, 2018-07-13 21:31 (800 d 00:00 ago) – Posting: # 19052
Views: 2,152

Hi,
Our firm is developing a multi-strength product which is a high potency, NTI oral dosage. The highest strength is 0.3 mg. The product guidance requests to use 0.3 mg x2 tablets for dosing and biowaive the lower strengths. However, our firm does not want to develop 0.3 mg. They have 0.15 mg as highest strength. Can I use 0.15 mg x4 for dosing and biowaive lower strengths? These strengths are similarly proportional, that is have the same tablet weight, the filler weight changes to compensate the API change.

Thank you

Complete thread:

Activity
 Admin contact
21,068 posts in 4,392 threads, 1,465 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Sunday 21:31 CEST (Europe/Vienna)

Data is not information.
Information is not knowledge.
And knowledge is certainly not wisdom.    Clifford Stoll

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