Bioequivalence and Bioavailability Forum • Comparisons of TPD, FDA and EMEA

sukimmm
●

2008-10-20 05:00
(6463 d 14:09 ago)

Posting: # 2562
Views: 3,716

Comparisons of TPD, FDA and EMEA [Regulatives / Guidelines]

Dear all,

I would like to have a kind of a brief comparison of the agencies (FDA, TPD and EMEA) in regards to bioequivalence. Something that says for example, that the BE criteria for TPD is on the Cmax, for the FDA is Cmax + CI for the Cmax, etc. (as you see I am a new statistician in this field).

Did someone already draft it ? (e.g. N of subject, design of choice, BE criteria, Tmax treatment, and all other subtles differences between the agencies).

This would ease my life at work. My colleagues rely on me ....

Thanks to all

Sukimmm

Helmut
★★★

Vienna, Austria,
2008-10-20 13:17
(6463 d 05:52 ago)

@ sukimmm
Posting: # 2563
Views: 3,451

Comparisons of TPD, FDA and EMEA

Post reply

Dear Sukimmm!

❝ I would like to have a kind of a brief comparison of the agencies [...].

❝ Did someone already draft it ?

Yes, David Dubins (Uni Toronto) did it. An excel-sheet containing comparisons is available at his site.
For details please consult our Guidance collection.

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sukimmm ● 2008-10-20 19:34 (6462 d 23:35 ago) @ Helmut Posting: # 2565 Views: 2,933	Comparisons of TPD, FDA and EMEA Post reply
	Wonderful ! Thanks for the info. This will be more than usefull ! Sukimmm.