Log in
Register|
ioanam ★ Romania, 2006-12-22 10:29 (7113 d 10:06 ago) Posting: # 414 Views: 7,019 |
|
|
Dear Sir, I have to perform a 3 way cross over pilot study. The test product is available in 4 strengths (e.q. 250, 500, 750 and 1000 mg) with dose proportionality between these strengths. The pharmacokinetics is not influenced by food. Is a good design for this study a 3 way crossover study in fasted conditions with 3 sequences, 3 treatments and 3 periods with: Test A – test product 4 x 250 mg Test B – test product 1000 mg Reference – reference (1000 mg)? Thank you and Marry Christmas! |
|
Helmut ★★★   Vienna, Austria, 2006-12-22 13:43 (7113 d 06:52 ago) @ ioanam Posting: # 417 Views: 5,762 |
|
|
Dear ioanam! ❝ I have to perform a 3 way cross over pilot study. ❝ The test product is available in 4 strengths (e.q. 250, 500, 750 and 1000 mg) with dose proportionality between these strengths. The pharmacokinetics is not influenced by food. ❝ Is a good design for this study a 3 way crossover study in fasted conditions with 3 sequences, 3 treatments and 3 periods with: ❝ Test A – test product 4 x 250 mg ❝ Test B – test product 1000 mg ❝ Reference – reference (1000 mg)? Yes, that’s a reasonable design, with the exeption that you should apply a six sequence design. For details see this post. If in a later stage you go for a pivotal study you should consult the regulatory agency, since e.g., some European regulators want to see for such a design (2 test formulations) a Bonferroni-corrected confidence interval (95% instead of 90%) in order to keep the patient’s risk at 5% (EMEA’s Points to Consider on Multiplicity Issues in Clinical Trials). — 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 |
|
ioanam ★ Romania, 2007-01-09 10:55 (7095 d 09:40 ago) @ Helmut Posting: # 443 Views: 5,696 |
|
|
❝ Yes, that’s a reasonable design, with the exeption that you should apply a six sequence design. For details see this post. ❝ ❝ If in a later stage you go for a pivotal study you should consult the regulatory agency, since e.g., some European regulators want to see for such a design (2 test formulations) a Bonferroni-corrected confidence interval (95% instead of 90%) in order to keep the patient’s risk at 5% (EMEA’s Points to Consider on Multiplicity Issues in Clinical Trials). Dear Sir, Thank you for this information and I want to ask you something else. I just found that our client want in the bioequivalence study to compare the higher strength for the test with the same strength of the reference marketed in Europe versus USA. Is this possible? In the bioequivalence guidelines is specified that the reference must be the innovator. I did not found other 3 way crossover studies to investigate this. Thank you. |
|
Helmut ★★★ Vienna, Austria, 2007-01-09 17:57 (7095 d 02:39 ago) @ ioanam Posting: # 444 Views: 5,811 |
|
|
Dear ioanam! ❝ I just found that our client want in the bioequivalence study to compare the higher strength for the test with the same strength of the reference marketed in Europe versus USA. Is this possible? In the bioequivalence guidelines is specified that the reference must be the innovator. I did not found other 3 way crossover studies to investigate this. So your comparisons will be: Test (1000 mg) vs. ‘Reference A’ (1000 mg) EU and Test (1000 mg) vs. ‘Reference B’ (1000 mg) US Why not? Of course ‘Reference A’ must be an innovator’s product registered within the EEA (European Economic Area) or Switzerland (Mutual Recognition Agreement-Country), and ‘Reference B’ the RLD. In my experience three-way BE studies are more common (and accepted) in the EU than in the USA. — 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 |
Ing. Helmut Schütz