Bioequivalence and Bioavailability Forum

balakotu ★ India, 2018-05-21 15:31 (2489 d 20:49 ago) Posting: # 18792 Views: 3,629	Replicate Study design for Brazil [Regulatives / Guidelines] Post reply
	Dear All, Brazil submission: Thus any body have any idea on Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil). If acceptable what is the acceptance criteria to be followed (USFDA/Europe Approach). Regards Kotu Edit: No need to post identical text twice within three days. The other post deleted (see the Forum’s Policy). [Helmut]

Helmut
★★★

Vienna, Austria,
2018-05-21 18:47
(2489 d 17:34 ago)

@ balakotu
Posting: # 18794
Views: 2,861

ABEL acc. to WHO

Hi Kotu,

❝ […] Acceptance off Bio equivalence studies conducted in Replicate study design by ANVISA (Brazil).

Replicate designs – although for average bioequivalence – are acceptable for the ANVISA for ages (even mentioned in the guidance).

❝ […] what is the acceptance criteria to be followed (USFDA/Europe Approach).

If you mean reference-scaling, the latter (actually the WHO’s). See this post. Confirmed by a Brazilian colleague earlier this month.

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Weidson ☆ Brazil, 2018-05-22 22:51 (2488 d 13:29 ago) @ balakotu Posting: # 18799 Views: 2,807	Replicate Study design for Brazil Post reply
	Dear balakotu The ANVISA have adopted the EMA's Approach. However, for you use this approach you need to convince them that their drug is highly variable. I hope I have helped you. Best Regards Weidson C. de Souza Edit: Post moved. [Helmut]