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Helmut ★★★   Vienna, Austria, 2013-08-06 15:51 (4298 d 18:12 ago) Posting: # 11223 Views: 9,917 |
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Dear all, EMA just published a “Concept paper on the development of product-specific guidance on demonstration of bioequivalence” (EMA/CHMP/423137/2013). From the paper: 4. Recommendation The Pharmacokinetic Working Party recommends drafting product-specific guidance on the demonstration of bioequivalence. It is planned that such guidance is first developed for immediate release formulations for oral use. The guidance is based on the general principles set out in the applicable overarching Guideline on the Investigation of Bioequivalence, and summarises in a standardised format the relevant design principles for bioequivalence demonstration. The following items should be addressed in the guidance:
5. Proposed timetable The first set of product-specific guidance is planned to be adopted at the CHMP meeting in October 2013 for release for public consultation. End of consultation is 30 Sep 2013. — 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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ElMaestro ★★★ Denmark, 2013-08-06 16:02 (4298 d 18:01 ago) @ Helmut Posting: # 11224 Views: 8,369 |
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Thank you for the info, Helmut. ❝ If required, a brief scientific rationale for the guidance will be provided. What does that mean? If required by whom? CHMP? Themselves? People who comment? I would hope they'd publish rationales in all cases. After all, the determination of PSGs at EMA will involve heavy discussion of each individual guidance with determination of pros and cons, challenges and solutions etc going back on forth between the members. There will be plenty of rationale behind the curtains. Plus, since guidelines are guidelines and not laws, knowing the rationale for each of the PK-workgroup's PSGs would allow applicants to better distinguish between must and should. — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2013-08-06 16:18 (4298 d 17:45 ago) @ ElMaestro Posting: # 11225 Views: 8,558 |
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Hi ElMaestro! ❝ ❝ If required, a brief scientific rationale for the guidance will be provided. ❝ What does that mean? If required by whom? CHMP? Themselves? People who comment? Duno. Next question. ❝ I would hope they'd publish rationales in all cases. Me too. This is lacking in most of FDA’s product-specific guidances.  ❝ […] since guidelines are guidelines and not laws, knowing the rationale for each of the PK-workgroup's PSGs would allow applicants to better distinguish between must and should. Definitely. Did you notice the term “guidance” instead of “guideline”? I have learned from John that – according to FDA’s thinking – the latter is considered more binding that the former. This was one of the reasons renaming the “Note for Guidance on Investigation of Biavailability and Bioequivalence” to “Guideline on Investigation of Bioequivalence”. I expect EMA to publish guidances on drugs mentioned in the Q&A first (omeprazole, clopidogrel, losartan, tacrolimus, ciclosporine, mycophenolate mofetil). How far will they reach? Problematic cases only? I don’t expect to see something similar to FDA’s API-specific guidances (currently 1115…). Edit 01/2014: Tacrolimus is scheduled for review in 2014 (see here). — 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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ElMaestro ★★★ Denmark, 2013-08-06 18:27 (4298 d 15:36 ago) @ Helmut Posting: # 11227 Views: 8,549 |
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Hi Helmut, ❝ Definitely. Did you notice the term “guidance” instead of “guideline”? I have learned from John that – according to FDA’s thinking – the latter is considered more binding that the former. This was one of the reasons renaming the “Note for Guidance on Investigation of Biavailability and Bioequivalence” to “Guideline on Investigation of Bioequivalence”. Yes, when I was a regulator noone was able to tell the regulatory status difference between a Guideline, Note for Guidance, Points to Consider and Q&A. The commission had no idea either, I think, because of lack of definitions in dir. 2001/83 etc. So the EMEA decided to abandon PtC's and NfG's altogether. I guess that makes it all a lot simpler. Unless of course you deal with regulators who find it hard to tell the difference between personal subjective opinion and universal law. Fortunately, this of course does not apply in the case of any member of the PK subgroup notch notch wink wink  — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2013-08-20 11:51 (4284 d 22:12 ago) @ ElMaestro Posting: # 11312 Views: 8,173 |
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Dear Helmut and ElMaestro, ❝ So the EMEA decided to abandon PtC's and NfG's altogether. My understanding was that "guideline" was preferred to "Note for guidance" because it is the wording used in Annex I to Directive 2001/83/EC. Nothing more. — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2013-08-20 14:54 (4284 d 19:09 ago) @ Ohlbe Posting: # 11315 Views: 8,092 |
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Drar Ohlbe, ❝ My understanding was that "guideline" was preferred to "Note for guidance" because it is the wording used in Annex I to Directive 2001/83/EC. Nothing more. And furthermore (no pun intended ), the CHMP rules of procedure allow CHMP to make "guidelines" through the working parties and drafting groups. Nothing more....well.... except "proposals" Anyone confused? With good reason. Directive 2001/83 on occasion mentions compliance with guidelines as well as principles. Principles and guidelines or their differences aren't really defined further (neither are they in the EMA regulation from the commission) But perhaps we need to distinguish between principles and guidelines since 2001/83 does not make use of the terms interchangeably?!? In that case ICH E6 is not a guideline, because the directive speaks of the principles of god clinical practice. And so on and so forth. We should make a list of terms that we'd like to see defined for practical use. On top of my list are the dreadful "pre-clinical tests and clinical trials" from article 10.3. — Pass or fail! ElMaestro |
Ing. Helmut Schütz