No reference-scaling for NTIDs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-08-02 14:57 (177 d 20:06 ago) – Posting: # 22498
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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.

Dif-tor heh smusma 🖖
Helmut Schütz
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