Bioequivalence and Bioavailability Forum

pravin17 ★ India, 2014-03-25 06:34 (4466 d 19:38 ago) Posting: # 12699 Views: 3,088	In-Vitro study [Regulatives / Guidelines] Post reply
	Dear Sir, As per USFDA OGD recomendation only Invitro study is require to be submitted, whether there any specific requirment in final study report or it is same as regular (E3 format). Thank You Pravin

Dr_Dan ★★ Germany, 2014-03-25 10:10 (4466 d 16:03 ago) @ pravin17 Posting: # 12701 Views: 2,556	In-Vitro study Post reply
	Dear Pravin the E3 format refers to clinical studies i.e. in vivo and would not be applicable for an in vitro study. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan

pravin17 ★ India, 2014-03-25 13:51 (4466 d 12:21 ago) @ Dr_Dan Posting: # 12705 Views: 2,523	In-Vitro study Post reply
	Dear Dr Dan, Please guide me-how report should be prepared, is there any specific guidline for In-vitro studies. Thank You Pravin

Dr_Dan
★★

Germany,
2014-03-26 09:37
(4465 d 16:35 ago)

@ pravin17
Posting: # 12713
Views: 2,467

In-Vitro study

Dear Pravin
As far as I know there is no specific guideline. I suggest to prepare the report more or less like a scientific publication:

I hope this helps
Kind regards
Dr_Dan

—
Kind regards and have a nice day
Dr_Dan