Bioequivalence and Bioavailability Forum

joyjac ★ Philippines, 2009-02-17 07:48 (6342 d 13:39 ago) Posting: # 3253 Views: 2,758	BE Reporting Format [Regulatives / Guidelines] Post reply
	Dear colleagues, I would appreciate it very much if you could share with me the format and contents of a BE Study Report for EU submission. Thanks and regards.

shankar ★ India, 2009-02-17 08:00 (6342 d 13:27 ago) @ joyjac Posting: # 3254 Views: 2,283	BE Reporting Format Post reply
	Hi, Please check in "Structure and Content of Clinical Study Reports (E3) guidelines." Here you will get the format of study report and I think there is no specific format for any regulatory authority. Regards, — Shankaranarayanan

Helmut
★★★

Vienna, Austria,
2009-02-17 15:26
(6342 d 06:01 ago)

@ shankar
Posting: # 3262
Views: 2,310

BE Reporting Format

Dear Shankaranarayanan!

❝ [...] "Structure and Content of Clinical Study Reports (E3) guidelines."

Yes (get it here).

@Joy: Nothing particular on BE reporting (except Section 3.8 of the BA/BE guideline) in the EU.

❝ [...] I think there is no specific format for any regulatory authority.

^^^
Not quite so: Brazil (2003), Canada (2004), Australia (2004), WHO (2006), ~~http://www.fda.gov/cder/ogd/DBE_tables.pdf~~ FDA (2007)... :-D

--
Edit: Link corrected for new FDA file structure. [Helmut]

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes