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RegisterNo reference-scaling for NTIDs [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2021-08-02 14:57 (173 d 08:52 ago) – Posting: # 22498
Views: 1,280
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.
» 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.
—
Dif-tor heh smusma 🖖
Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG prasad.v 2021-07-29 10:33 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No acceptance criteria widening for AUC in Europe vixen 2021-07-30 18:44
- No reference-scaling for NTIDsHelmut 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
Ing. Helmut Schütz