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heritage ☆ India, 2018-05-05 08:25 (2506 d 05:26 ago) Posting: # 18755 Views: 4,277 |
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One drug has been approved as IR tablet given 100 mg bid (total dose 200 mg). We want to make one ER formulation of 230 mg which can be given once daily. I need help in following issues 1. What should be the design? 2. Which PK parameter I should be looking at? 3. Should I do fasting or fed study? 4. Should I targeting BE in Cmax or AUC? Please give me some reading material or link to any post wherein this had been already discussed Thanks in advance Edit: Category changed; see also this post #1. [Helmut] |
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bebac_fan ☆ US, 2018-05-05 19:08 (2505 d 18:42 ago) @ heritage Posting: # 18756 Views: 3,384 |
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I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA. In this case, comparative efficacy, rather than BE, will be considered pivotal. |
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Obinoscopy ★ USA, 2018-05-15 21:04 (2495 d 16:47 ago) @ bebac_fan Posting: # 18764 Views: 3,128 |
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Dear bebac_fan, ❝ I think this would need to go through a NDA/505(b)(2) pathway rather than an ANDA. ❝ I share the same view with you on this. However I have a case where a BE study was conducted comparing Metronidazole tablet (Reference) with Metronidazole soft gel (test). Both were IR. Is this acceptable? Regards, — Scopy |
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jag009 ★★★ NJ, 2018-05-18 18:33 (2492 d 19:18 ago) @ Obinoscopy Posting: # 18786 Views: 3,060 |
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Hi, ❝ However I have a case where a BE study was conducted comparing Metronidazole tablet (Reference) with Metronidazole soft gel (test). Both were IR. Is this acceptable? Have you read this guidance? FDA John |
Ing. Helmut Schütz