Bioequivalence and Bioavailability Forum • India, where the work is done

Helmut
★★★

Vienna, Austria,
2013-10-31 03:00
(4609 d 15:51 ago)

Posting: # 11829
Views: 6,868

India, where the work is done [Off Topic]

Dear all,

interesting survey (AAPS Annual Meeting 2012): FDA’s data (2011/08 – 2012/01) of 386 approved ANDA submissions (IR & ER): 723 BE studies (384 fasted, 339 fed).

               fasted  fed

India            50%   50%

USA              35%   27%

Canada           15%   19%

Germany           3%   <2%

Czech Republic  <~1%   <2%

Jordan          <~1%   <2%

UK              <~1%   <2%

Don’t try to add the percentages…

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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jag009 ★★★ NJ, 2013-10-31 15:44 (4609 d 03:07 ago) @ Helmut Posting: # 11840 Views: 5,463	India, where the work is done Post reply
	Hi Helmut, I am more interested, if it exists, the % of bioanalytical work done in US vs india. John

Helmut
★★★

Vienna, Austria,
2013-10-31 16:08
(4609 d 02:43 ago)

@ jag009
Posting: # 11842
Views: 5,489

Biosamples “Up in the Air”?

Post reply

Hi John,

❝ I am more interested, if it exists, the % of bioanalytical work done in US vs india.

The title of Poster M1377 is “Statistics on Bioanalytical-site Country of Generic Drugs Recently Approved in the USA”
From the text it is not clear to me whether the FDA looked really on the bioanalytical part only or on entire studies. Quote

The current study was undertaken to determine the location of sites where the BE studies in support of ANDAs were conducted.

—
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