Bioequivalence and Bioavailability Forum • What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG

What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG [Regulatives / Guidelines]

posted by prasad.v – India, 2021-07-29 12:33 (1792 d 19:02 ago) – Posting: # 22486
Views: 5,800

Dear All,

Little bit confusion raised as the Gliclazide is a NTI molecule, what would be the study design for gliclazide 80mg tablet BE study for Europe, WHO & HKG submission.

Can we do the two-way crossover or full replicate fast and fed by widening AUC?
Can we do the two-way crossover or full replicate fast and fed by widening AUC and Cmax?

Regards,
V. Prasad

Complete thread:

What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKGprasad.v 2021-07-29 10:33 [Regulatives / Guidelines]
- No acceptance criteria widening for AUC in Europe vixen 2021-07-30 18:44
- No reference-scaling for NTIDs Helmut 2021-08-02 14:57
- What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG drgunasakaran1 2021-08-06 08:47