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pravin17 ★ India, 2010-10-05 16:22 (5735 d 06:14 ago) Posting: # 5996 Views: 2,706 |
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Dear friends, I am preparing protocol of BE study for 505 2(b) submission In that suspension is compared against capsule. My Qstion is What will be the Bioequivalence criteria for this study? Pravin Borde Edit: Subject line changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2010-10-05 17:26 (5735 d 05:10 ago) @ pravin17 Posting: # 5999 Views: 2,234 |
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Dear Pravin, ❝ I am preparing protocol of BE study for 505 2(b) submission ❝ In that suspension is compared against capsule. ❝ My Qstion is What will be the Bioequivalence criteria for this study? A little more info would be a good idea: Which drug, and is it a BE study for safety, efficacy or both? What can you tell about the therapeutic window? And above all: What is the purpose of your study? At any rate, 505(b)(2)'s are new drugs and as such you do have some freedom in your approach so you do have a possiblity to approach the FDA in a pre-IND meeting and suggest whatever acceptance range you find relevant. — Pass or fail! ElMaestro |
Ing. Helmut Schütz