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msmnainar ★ India, 2013-02-14 09:08 (4447 d 10:31 ago) Posting: # 10018 Views: 7,921 |
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Dear All Could you confirm how to combine the initial study BE data with add-on study, considering the Healthy Canada regulations. Request you to address the following queries,
Thanks and Regards Edit: Category changed. [Helmut] — Sundar. M |
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drgunasakaran1 ★★  2013-02-14 10:54 (4447 d 08:45 ago) @ msmnainar Posting: # 10020 Views: 6,790 |
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Dear Mr Msmnainar, As per Canadian BE guideline, if the study is run with the appropriate size and the standards are not met, the sponsor may add more subjects (a minimum of 12). The same protocol should be used (i.e., same formulations, same lots, same blood sampling times, a minimum number of 12 subjects, etc.). The choice to use this strategy, as with all designs, should be declared and justified a priori. The level of confidence should be adjusted using the Bonferroni procedure. The t-value should be that for p=.025 instead of .05. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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msmnainar ★ India, 2013-02-14 11:39 (4447 d 08:00 ago) @ drgunasakaran1 Posting: # 10021 Views: 6,865 |
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Hello Dr. Gunasekaran We have followed all the procedure, as per canadian guideline, My question is to obtain final results how to combine the both the data. How to adjust the p value etc., — Sundar. M |
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Helmut ★★★   Vienna, Austria, 2013-02-14 14:32 (4447 d 05:07 ago) @ msmnainar Posting: # 10024 Views: 6,789 |
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Dear Msmnainar, forget Add-ons (see below). For Methods C and D see:
— 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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msmnainar ★ India, 2013-02-14 14:40 (4447 d 04:58 ago) @ Helmut Posting: # 10025 Views: 6,750 |
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Dear HS Thanks for your valuable information. — Sundar. M |
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Helmut ★★★ Vienna, Austria, 2013-02-14 14:22 (4447 d 05:16 ago) @ drgunasakaran1 Posting: # 10023 Views: 6,957 |
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Dear Dr Gunasakar, I disagree. Add-on studies (with αadj 0.025) were mentioned in the Jan 2010 draft, but dropped in the final (May 2012) guidance. Only group sequential designs (Pocock 1977; αadj 0.0294) and adaptive designs (Potvin et al. 2008; Method C: αadj 0.05 or 0.0294) are acceptable. Since Pocock’s method was never validated for BE studies (only: superiority testing, parallel design, n1=n2, known variance, Z instead of t) I would only go with Method C (or alternatively with Method D by Montague et al. 2011 if T/R is expected to be 0.9; αadj 0.028). — 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