Log in
Register|
cats99 ● 2011-02-13 10:50 (5610 d 14:13 ago) Posting: # 6621 Views: 3,863 |
|
|
Dear All, I am planning to prepare BE study design. In most BE study, it is going to crossover study. When the drugs are HVD(P) in this setting, there are many methods to adjust BE criterion such as SABE. In case of parallel design, however, I didn't find such method. Characteristics of my study drug have long half-life and large CV (Reference drug is Remicade) and there are no references conducting cross-over study for Remicade. Therefore, I can't get a intra CV for my study and also this drug has long-half life and antibody could be made. So, cross-over design was not apapted so that we are considering parallel design. My concern is that in case of parallel design with large variation like HVDs, if we use the current BE criterion of our regulatory, it is more likely to fail the study. Could you please let me know the way to expand BE criterion for parallel design? Best regards, BK Park. |
|
Dr_Dan ★★ Germany, 2011-02-16 12:10 (5607 d 12:52 ago) @ cats99 Posting: # 6635 Views: 3,176 |
|
|
Dear BK Park. ❝ Could you please let me know the way to expand BE criterion for parallel ❝ design? If you have to use a parallel group design you will not be able to claim widened acceptance ranges for BE, sorry  . In order to minimize the risk to fail the study and to adjust the sample size (important for a highly variable drug) I suggest to use an adaptive parallel design. So you start your study with an in-study pilot part and after an interim analysis you can (hopefully) predict the outcome and adjust the sample size.Kind regards Dan — Kind regards and have a nice day Dr_Dan |
|
Dr RCG ☆ 2011-04-06 07:24 (5558 d 18:38 ago) @ cats99 Posting: # 6864 Views: 2,852 |
|
|
As suggested, you can do pilot study and then based on the results you can adjust the sample size, Also consider what T/R ratio are you expecting. Then calculate the actual size of the pivotal study. |
Ing. Helmut Schütz