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Mithu ★ India, 2023-05-04 06:59 (348 d 11:02 ago) Posting: # 23541 Views: 1,601 |
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Hello All, My question is, "is it mandatory to have 505b(2) application bio-equivalent to current reference listed drug?" regards, Mithu |
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dshah ★★ India/United Kingdom, 2023-05-05 15:38 (347 d 02:22 ago) @ Mithu Posting: # 23545 Views: 1,308 |
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Hello Mithu! As we rely on existing PKPD relationship, toxicity data and other pharmacology data of reference drug, the BE is required. Regards, Divyen |
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Mithu ★ India, 2023-05-11 09:58 (341 d 08:03 ago) @ dshah Posting: # 23548 Views: 1,234 |
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Hi Divyen, Thank you for your reply. regards, Mithu |
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Achievwin ★ US, 2023-05-05 18:08 (346 d 23:53 ago) @ Mithu Posting: # 23546 Views: 1,342 |
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Hello Mithu: 505 (b)(2) is all about the submission and marketing strategy. Most of the 505(b)(2) applications take BE route as drug Chemistry, safety and efficacy along with biopharmaceutics is already known and BE is used as a knowledge (claim) gap bridging approach. There are other means you can get 505(b)(2. Please review different guidance (FDA, EMA etc.) or white papers on 505(b)(2). Hope this helps |
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Mithu ★ India, 2023-05-11 09:58 (341 d 08:02 ago) @ Achievwin Posting: # 23549 Views: 1,240 |
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Hello Achievwin, Thank you for your reply. regards, Mithu |
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