Log in
Register|
Dr_Dan ★★ Germany, 2012-09-18 18:10 (5031 d 12:40 ago) Posting: # 9235 Views: 4,690 |
|
|
Hi friends we try do develop a generic MR formulation containing xxx. The originator has two MR formulations (A and B; same strength of xxx) on the market. For A the SmPC states no food effect, for formulation B a significant food effect was demonstrated. We aim for formulation A and I would like to avoid the single-dose fasted study. Now my question: Does Appendix 1 of guideline CPMP/EWP/280/96 Corr * refer to the formulations or to the drug entities itself? I am looking forward to your reply. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
|
Helmut ★★★   Vienna, Austria, 2012-09-18 21:48 (5031 d 09:02 ago) @ Dr_Dan Posting: # 9238 Views: 3,873 |
|
|
Hi Dan! ❝ The originator has two MR formulations (A and B; same strength of xxx) on the market. For A the SmPC states no food effect, for formulation B a significant food effect was demonstrated. Funny. If I could put regulator’s boots on I would politely suggest the innovator to take formulation B off the market. ❝ We aim for formulation A … Reasonable.  ❝ … and I would like to avoid the single-dose fasted study. Hhm. ❝ Does Appendix 1 of guideline CPMP/EWP/280/96 Corr * refer to the formulations or to the drug entities itself? IMHO the former. I would suggest to be a little patient until part II of the new MR draft is published (announced for the end of this month). Maybe we see some enlightening stuff (SD/MD, fasting/fed, etc). P.S.: For part I see here. — 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 |
|
Ohlbe ★★★ France, 2012-09-25 20:32 (5024 d 10:18 ago) @ Helmut Posting: # 9252 Views: 3,700 |
|
|
Dear Helmut, ❝ I would suggest to be a little patient until part II of the new MR draft is published (announced for the end of this month). Maybe we see some enlightening stuff (SD/MD, fasting/fed, etc). You'll have to be a bit more patient. The new draft is not on the list of guidelines and concept papers adopted by the CHMP this month. Regards Ohlbe — Regards Ohlbe |
|
Helmut ★★★ Vienna, Austria, 2012-09-25 22:17 (5024 d 08:33 ago) @ Ohlbe Posting: # 9254 Views: 3,709 |
|
|
Dear Ohlbe! ❝ The new draft is not on the list of guidelines and concept papers adopted by the CHMP this month. THX! Patience is any scientist’s first virtue. — 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 |
|
The Outlaw Torn ★ Europe, 2013-01-17 14:38 (4910 d 15:12 ago) @ Helmut Posting: # 9885 Views: 3,423 |
|
|
❝ ❝ The new draft is not on the list of guidelines and concept papers adopted by the CHMP this month. Ladies and gentlemen (and others), Is it on this month's list?! Really, has anyone heard anything, factual or otherwise--I'd settle for rumour or innuendo at this point--about this "MR draft"? Thank you, Torn |
|
Helmut ★★★ Vienna, Austria, 2013-01-17 16:08 (4910 d 13:42 ago) @ The Outlaw Torn Posting: # 9886 Views: 3,450 |
|
|
Hi Torn! ❝ Ladies and gentlemen (and others), Great salutation. ❝ Is it on this month's list?! Duno. Not in December 14th list. ❝ Really, has anyone heard anything, factual or otherwise--I'd settle for rumour or innuendo at this point--about this "MR draft"? Jan Neuhauser (Austrian AGES) will give a presentation at Informa’s 9th Annual BA/BE, Dissolution and Biowaivers conference on May 15th: Delivering an insight on the new oral modified release products section II: Pharmacokinetic and clinical evaluation
— 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 |
|
The Outlaw Torn ★ Europe, 2013-01-18 09:01 (4909 d 20:49 ago) @ Helmut Posting: # 9888 Views: 3,346 |
|
|
❝ Jan Neuhauser (Austrian AGES) will give a presentation at Informa’s 9th Annual BA/BE, Dissolution and Biowaivers conference on May 15th: ❝ ❝ ❝ • Outlining timelines for draft guidance, public consultation and release This makes it sound like the draft will not come out before the 15th of May! There must be trouble in the henhouse (PK working party) if they have to keep adding bungee cord to their already extended deadline. Appropos modification of subject line! Thank you for the feedback. |
|
Ohlbe ★★★ France, 2013-01-25 19:58 (4902 d 09:52 ago) @ The Outlaw Torn Posting: # 9914 Views: 3,272 |
|
|
Dear all, The draft is still not on the list of documents adopted by the CHMP in January. It looks like EGA is not very optimistic on the publication date for the organisation of their 4th symposium on bioequivalence: until recently the website said more details would be available in January 2013, now June 2013... Regards Ohlbe — Regards Ohlbe |
|
ElMaestro ★★★ Denmark, 2013-01-25 21:01 (4902 d 08:49 ago) @ Ohlbe Posting: # 9915 Views: 3,332 |
|
|
Dear all, ❝ It looks like EGA is not very optimistic on the publication date for the organisation of their 4th symposium on bioequivalence: until recently the website said more details would be available in January 2013, now June 2013... Let's keep our heads cool now. The earth has existed without this MR guideline update ]for 4.54 billion years, so what difference can 6 months possibly make?  — Pass or fail! ElMaestro |
Ing. Helmut Schütz