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AngusMcLean ★★ USA, 2015-07-13 16:47 (3649 d 05:59 ago) (edited on 2015-07-14 23:59) Posting: # 15075 Views: 7,850 |
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We have performed the usual comparison BE study with 2 sequences (AB, BA), 2 Periods, Latin Square Design, comparing two modified release formulations A and B in 16 subjects. Now after completing the cross-over treatments we are bringing back the same 16 subjects and we are going to administer Formulation B with different meals on the same date. {We realize that the best way of doing such a comparison would have been a 3 way cross over balanced study design in the first place}. The formulation comparison (B v A) for the randomized cross-over will of course be done as usual in Phoenix WinNonlin 6.4. We are going to combine the PK data parameters from Formulation B from Phase 1 and Phase 2 and compare them with the PK parameters from the added arm (formulation B) with different meals. I am thinking to treat the data as esentially a parallel group comparison. We believe that such a comparison, although inconsistent with regulatory requirements, will provide useful information at this stage of the programme. Any thoughts are welcome, Angus Edit: title changed to lower case [Ohlbe] |
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ElMaestro ★★★ Denmark, 2015-07-13 19:39 (3649 d 03:07 ago) (edited on 2015-07-14 23:59) @ AngusMcLean Posting: # 15076 Views: 6,738 |
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Hi Angus, What are you really trying to achieve? I am not sure I can think of any situation that would arise our of the normal and which would be reasonably addressed by your approach. I am sure there might be alternatives. Can you give more background? — Pass or fail! ElMaestro |
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Dr_Dan ★★ Germany, 2015-07-13 20:00 (3649 d 02:47 ago) (edited on 2015-07-14 23:59) @ ElMaestro Posting: # 15078 Views: 6,599 |
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Hi Angus, You are talking about a pilot study where you intend to add a third arm, right? And you just want to get more information about your test product? IMHO -since this would be no confirmatory or pivotal study- you can do what you want in order to get to know your product. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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intuitivepharma ☆ India, 2015-07-15 11:43 (3647 d 11:03 ago) @ Dr_Dan Posting: # 15085 Views: 6,504 |
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Dear All, As we are aware that this is a crippled design [though not intentionally intended], now what should be the best statistical approach that should be employed to have a better understanding [as this is only a pilot study] of true formulation performance [Treatment – C] from the available data of the add-on arm. There would be two sequences as of now, ABC & BAC. Should I,
Regards, IP. — Thanks & Regards, IP. |
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AngusMcLean ★★ USA, 2015-07-14 02:02 (3648 d 20:44 ago) (edited on 2015-07-15 00:00) @ ElMaestro Posting: # 15079 Views: 6,642 |
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There is no alternative; what has been done has been done. For the last add-on arm the breakfast is different. Thus we looking for information pertinent to the difference in breakfast causing a difference in bio availability. |
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Dr_Dan ★★ Germany, 2015-07-16 11:18 (3646 d 11:28 ago) @ AngusMcLean Posting: # 15093 Views: 6,471 |
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Dear AngusMcLean Was this a pilot study: Yes or No? What was stated in the study protocol? The additional arm added with an amendment? Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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ElMaestro ★★★ Denmark, 2015-07-16 17:21 (3646 d 05:25 ago) @ AngusMcLean Posting: # 15095 Views: 6,382 |
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Hi Angus, How about just writing a new protocol, conduct a new study, semi-randomised uncontrolled and with one arm? Invite the same subjects to sign an ICF, use the rand. code from last time. Add arms as you please, to investigate aspects of the food effect. Technically, I guess this makes certain formalities easier. You'll end up in possession of data that you can analyse the same way in an exploratory fashion. From a GCP/Helsinki perspective this is "at least as OK" as adding an arm (anticipated benefit and risk same), and the paperwork and struggle with authorities/IRB's may be less. And you can avoid the issue of reconsenting, reopening a database, re-everything. — Pass or fail! ElMaestro |
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d_labes ★★★ Berlin, Germany, 2015-07-17 10:12 (3645 d 12:35 ago) @ ElMaestro Posting: # 15100 Views: 6,385 |
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Hi ElMaestro, hi Dan, as I understand Angus statement: "It's all over now, baby blue" Bob Dylan. Or in German: "Alle Messen sind gesungen". He has already performed the study as described. — Regards, Detlew |
Ing. Helmut Schütz