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jag009 ★★★ NJ, 2012-11-07 23:18 (4969 d 05:59 ago) Posting: # 9522 Views: 8,722 |
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Hi, Has anyone ever attempted an IVIVC for a "biphasic" drug delivery product such as one containing 2 population of beads (either IR and ER beads or ER beads with different release rates/coating)? Should one attempt the IVIVC on the drug product as a single entity or attempt to evaluate IVIVC for each of the 2 component? I know it sounds kind of weird but am just thinking out of the blue... Thanks John |
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Helmut ★★★   Vienna, Austria, 2012-11-08 01:27 (4969 d 03:50 ago) @ jag009 Posting: # 9523 Views: 7,663 |
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Hi John, ❝ I know it sounds kind of weird but am just thinking out of the blue... Doesn’t sound weird to me.  I think that Jennifer Dressman (chair of FIP’s Focus Group on BCS (Biopharmaceutics Classification System) and Biowaiver) tried that a while ago – without success. Ask her.— 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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SDavis ★★ UK, 2012-11-19 09:27 (4957 d 19:50 ago) @ jag009 Posting: # 9548 Views: 6,424 |
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John, I would build my model on the single entity/whole capsule; I think this is fairly common formulation design and I've certainly seen IVIVCs successfully constructed around these to aid development. I don't know if anyone has tried to apply for a biowaiver but I will ask our consulting group Simon PS found an example; Chittenden J. In Vitro / In Vivo Correlation (IVIVC) Development for a model compound with release rate specific bioavailability. [poster abstract T2037]. Presented at: AAPS Annual Meeting; November 11-15; San Diego, California. I have this in PDF but not sure how to attach here — Simon Senior Scientific Trainer, Certara™ [link=https://www.youtube.com/watch?v=xX-yCO5Rzag[/link] https://www.certarauniversity.com/dashboard https://support.certara.com/forums/ |
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Helmut ★★★ Vienna, Austria, 2012-11-19 16:24 (4957 d 12:52 ago) @ SDavis Posting: # 9553 Views: 6,359 |
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Hi Simon! ❝ John, I would build my model on the single entity/whole capsule; Hhm. Once the capsule releases the beads (generally within less than 30 minutes) they act as independent doses, IMHO. Most commonly one part is IR and the other part controlled or delayed release. ❝ I think this is fairly common formulation design True. ❝ and I've certainly seen IVIVCs successfully constructed around these to aid development. Interesting! ❝ I don't know if anyone has tried to apply for a biowaiver but I will ask our consulting group Biowaivers are not applicable to controlled / delayed release formulations (only IR). ❝ PS found an example; […] I have this in PDF but not sure how to attach here Sorry, not possible. @John: Use Simon’s ![[image]](img/email.png) e-mail link to contact him directly.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2012-11-20 18:07 (4956 d 11:09 ago) @ Helmut Posting: # 9561 Views: 6,411 |
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Hi Guys, ❝ ❝ John, I would build my model on the single entity/whole capsule; ❝ ❝ Hhm. Once the capsule releases the beads (generally within less than 30 minutes) they act as independent doses, IMHO. Most commonly one part is IR and the other part controlled or delayed release. The problem I am facing is the time scaling part. My data shows two distinct time scaling "regions" and I don't see how I can do the time scaling on the single entity/whole capsule since it's an IR & ER combination formulation. ❝ Biowaivers are not applicable to controlled / delayed release formulations (only IR). Why not? It's and IR/ER combo. I checked a few SBOAs and there are a few submissions with IVIVCs. However, those IVIVCs failed because the prediction errors exceeded the regulatory limits. Nonetheless the companies filed their IVIVCs and FDA's rejected the IVIVCs based on the prediction errors. I don't get it. Why did they file if the results were no good  Thanks John |
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ElMaestro ★★★ Denmark, 2012-11-20 18:19 (4956 d 10:57 ago) @ jag009 Posting: # 9562 Views: 6,355 |
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Hi John, ❝ I don't get it. Why did they file if the results were no good In some companies they have a bad habit of only trashing projects when the top management has asked the standard question "Have you done everything in your power to try and save the project?" and received a firm "Yes". Desperate submission of lousy junk then forms an integrated part of this silly game. It isn't about getting a drug approved - it is all about avoiding getting fired. I believe they call it Operational Excellence etc. Not sure if this is the case here, but I just feel I have to offer this is a possible or even likely explanation. Two peanuts come valking down ze strasse.... — Pass or fail! ElMaestro |
Ing. Helmut Schütz