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jag009 ★★★ NJ, 2012-10-06 00:37 (5016 d 02:45 ago) Posting: # 9320 Views: 3,554 |
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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 Does anyone have access to the FDA draft guidance of mesalamine DR tablets with the pAUC requirements?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 |
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Ohlbe ★★★ France, 2012-10-06 00:45 (5016 d 02:37 ago) @ jag009 Posting: # 9321 Views: 3,025 |
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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 |
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jag009 ★★★ NJ, 2012-10-06 01:00 (5016 d 02:22 ago) @ Ohlbe Posting: # 9323 Views: 2,918 |
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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