prasad.v
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India,
2021-07-29 10:33
(49 d 10:59 ago)

Posting: # 22486
Views: 1,422
 

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

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.
  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?

Regards,
V. Prasad
vixen
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Czechia,
2021-07-30 18:44
(48 d 02:48 ago)

@ prasad.v
Posting: # 22488
Views: 1,031
 

 No acceptance criteria widening for AUC in Europe

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
Helmut
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Vienna, Austria,
2021-08-02 14:57
(45 d 06:35 ago)

@ prasad.v
Posting: # 22498
Views: 975
 

 No reference-scaling for NTIDs

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.

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drgunasakaran1
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2021-08-06 08:47
(41 d 12:45 ago)

@ prasad.v
Posting: # 22513
Views: 918
 

 What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG

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 :confused: :confused:
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

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
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