reference replicate design [Design Issues]

posted by VG – India, 2014-01-13 13:18 (4545 d 07:58 ago) – Posting: # 12160
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Dear all

Please let me know if reference replicate design (partial and fully replicate) is acceptable to the KFDA (Korea) for highly variable drugs. If so which methodology is to be followed (USFDA or EMA).


Regards

VG

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