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cakhatri ★ India, 2013-02-28 12:37 (4868 d 19:13 ago) Posting: # 10128 Views: 3,406 |
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Dear Members, We are planning to conduct BE study on Tenofovir (Class III) + Emtricitabine (class I) for a market which follows EU guidelines. As per the EU guidelines "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE"-Aug 2010, following is recommended BCS-based biowaiver are applicable for immediate release FC products if all active substances in the FC belong to BCS-class I or III and the excipients fulfil the requirements outlined in section IV.2. Otherwise in vivo bioequivalence testing is required. The guidelines specifes "all active substances in FC belong to BCS- Class I or III" does this imply that if there are two active ingredients (as in our case) both of them should be either class I or Class III. What would be the interpretation for one drug being Class I and other being Class III, can still BCS biowaiver be claimed Regards Chirag |
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Helmut ★★★   Vienna, Austria, 2013-02-28 18:56 (4868 d 12:54 ago) @ cakhatri Posting: # 10135 Views: 2,762 |
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Hi Chirag! ❝ BCS-based biowaiver are applicable for immediate release FC products if all active substances in the FC belong to BCS-class I or III and the excipients fulfil the requirements outlined in section IV.2. Otherwise in vivo bioequivalence testing is required. ❝ ❝ What would be the interpretation for one drug being Class I and other being Class III, can still BCS biowaiver be claimed What do you want to interpret here? You can apply for (not claim) a biowaiver if the APIs are either Class I or III. API│ BCS — 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 |
Ing. Helmut Schütz