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jag009 ★★★ NJ, 2012-04-18 19:26 (5184 d 10:27 ago) Posting: # 8445 Views: 5,112 |
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Hi everyone, Can someone give me a history lesson on the differences between the old and new FDA requirement on BE studies with respect to the fed study? Correct me if I am wrong... The previous requirement was a 3-way (Test Fast, Test Fed, Reference Fed) with Cmax based on T/R ratios AUCs based on 90% CI? Thanks John |
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jag009 ★★★ NJ, 2012-04-19 21:39 (5183 d 08:14 ago) @ jag009 Posting: # 8448 Views: 4,496 |
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Sorry everyone, I wanted to edit my question but I couldn't... Does anyone have access to the old FDA BA/BE guidance that was issued about 199x? It was the guidance which required a SD fast study, a MD fast study and a 3-way food effect study? The food effect study BE critera was based on point estimates of Cmax and AUC to be within 80-125%? Question... Was the guidance applicable to both immediate and extended release products? Thanks john |
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drgunasakaran1 ★★  2012-05-01 15:23 (5171 d 14:30 ago) @ jag009 Posting: # 8483 Views: 4,252 |
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❝ Does anyone have access to the old FDA BA/BE guidance that was issued about 199x? Dear Mr John, Please find below the requested old FDA Guidances FDA Guidance 1 FDA Guidance 2 — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz