Bioequivalence and Bioavailability Forum

Hi Prasad,

Can't comment on the WHO or HKG, but in Europe you would be only allowed to widen the acceptance criteria for Cmax (not for AUC) and under the conditions that:

• you demonstrate in a replicate design study that the reference IS CV for Cmax is above 30%,
  
• a wider difference in Cmax is considered clinically irrelevant based on a sound clinical justification

Cheers,
vixen

Hi Prasad,

❝ 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.

If you are referring to Hong Kong, guidances of China’s CDE are applicable.

Adding to what vixen wrote: Reference-scaling (ABEL: the EMA, most jurisdictions including the WHO or RSABE: U.S. FDA and China’s CDE) for NTIDs is not acceptable.

Dear Mr Prasad,

❝ 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.

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

   ❝

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

Gliclazide falls under the category of NTI
As per the bioequivalence studies submitted to countries in EU Regions/EMA, most of the studies were conducted as two period, two way, cross over design for Gliclazide.

Reference 1: EU-procedure number: NL/H/1701/001/DC
Reference 2: DK/H/2376/001-002/DC
Reference 3: FR/H/171/02/DC
Reference 4: PL 42176/0005-06