Log in
Register|
jag009 ★★★ NJ, 2012-10-06 00:37 (5011 d 06:28 ago) Posting: # 9320 Views: 3,531 |
|
|
Hi, For education... Does anyone have access to the FDA draft guidance of mesalamine DR tablets with the pAUC requirements? I have the GPhA slide presentation (2012) but I can't find the guidance on FDA's website. Thanks John |
|
Ohlbe ★★★ France, 2012-10-06 00:45 (5011 d 06:19 ago) @ jag009 Posting: # 9321 Views: 3,002 |
|
|
Dear John, They were posted in the September release on the web site. There are 3 guidance documents available depending on the potency, here, here and here. All 3 recommend AUC8-48. Regards Ohlbe — Regards Ohlbe |
|
jag009 ★★★ NJ, 2012-10-06 01:00 (5011 d 06:05 ago) @ Ohlbe Posting: # 9323 Views: 2,893 |
|
|
Thanks Onlbe, The FDA site drives me crazy sometime... Why don't they update the complete list instead of having an extra page for "Newly Added Guidance Documents" |
Ing. Helmut Schütz