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Compliance ★ India, 2013-01-16 10:48 (4910 d 04:43 ago) Posting: # 9861 Views: 3,681 |
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Dear All, Is it possible to have truncation (due to long half life) study design for ER formulation? If you have any information please share. Regards, compliance |
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Helmut ★★★   Vienna, Austria, 2013-01-16 15:20 (4910 d 00:11 ago) @ Compliance Posting: # 9865 Views: 3,082 |
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Dear Compliance, ❝ Is it possible to have truncation (due to long half life) study design for ER formulation? If you have any information please share. I was always wondering what might be the rationale of developing an ER formulation of a long half life drug. Maybe you can enlighten me. Do you have data from a pilot study demonstrating the half life is ‘essentially similar’ (pun!) to an IR formulation? If yes truncation should be possible. If the apparent elimination is longer compared to what you see after IR I would never truncate (absorption not completed). In BE we assess rate and extent of absorption. In such a case slight differences seen at 72 hours may be more pronounced at later times. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2013-01-16 16:59 (4909 d 22:33 ago) @ Helmut Posting: # 9867 Views: 2,970 |
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Hi Helmut, ❝ I was always wondering what might be the rationale of developing an ER formulation of a long half life drug. Maybe you can enlighten me. Marketing purpose, line extension. My former company once made an ER formulation of a drug with 20 hrs IR half-life (metabolites are even longer). Goal was to show a 20% decrease in Cmax and remain bioequivalent to IR for AUC --> claim less side effect due to lower Cmax. Back then we sampled beyond 72 hrs. It was a 505(b)2. John |
Ing. Helmut Schütz