MR generic application [Regulatives / Guidelines]

posted by vixen – Czechia, 2020-03-23 18:40 (248 d 08:29 ago) – Posting: # 21296
Views: 1,409

Hi Mikkabel,
More details are needed to determine what we are dealing with here:
- presumably it's an application for Europe?
- is it a single or multiple unit formulation?
- what does the reference SmPC say about intake with/without food?
- is accumulation expected?
- do all three strengths meet the general biowaiver criteria per section 4.1.6 of the Guideline on the investigation of bioequivalence?
- is the shape of all three strengths similar?
- which two strengths represent the extremes? consider it separately for each of the factors listed by section 6.6. of EMA MR Guideline.

Are you familiar with Annex IV to the EMA Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms?

Cheers,
vixen

Complete thread:

Activity
 Admin contact
21,213 posts in 4,426 threads, 1,483 registered users;
online 16 (0 registered, 16 guests [including 12 identified bots]).
Forum time: Friday 03:10 UTC (Europe/Vienna)

Biostatistician. One who has neither the intellect for mathematics
nor the commitment for medicine but likes to dabble in both.    Stephen Senn

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