Bioequivalence and Bioavailability Forum • CVintra # CVinter # CVtotal

CVintra # CVinter # CVtotal [Regulatives / Guidelines]

posted by drmuneesh – 2008-11-28 11:37 (6047 d 09:42 ago) – Posting: # 2830
Views: 7,880

Dear HS,

No, I am not talking about the same drug. I have done two studies with two different drugs. I have done one cross-over pilot with drug A which is a known highly variable drug and now I want to plan a pivotal two-way cross-over study. I have done another parallel Pilot with drug B with very long half and now want to plan a pivotal parallel study. I will elaborate my query as under-
Case-1: I have done a two-way cross-over pilot study with drug A and I have calculated the sample size for the pivotal study using SAS considering intra-subject CV of 0.5363 and observed %T/R ratio of 0.9148. The sample size calculated is 175 for two-way cross-over pivotal study as programmed. As the intra-subject CV is > 30% and the drug is known to be highly variable and therefore, I want to use the replicate (four-way cross-over) study design, in that case can I do the pivotal four-way cross-over study with at least half the number of subjects i.e. 88?

Case-2: I have done another pilot study with parallel design for a very long half-life drug B and I have calculated the sample size for the pivotal study using SAS considering total CV of 0.16 and observed %T/R ratio of 112.08. The sample size calculated is 27 for two-way cross-over study as programmed. In that case can I do the pivotal parallel study with at least double the number of subjects i.e. 54?

Please suggest.

Regards
Dr Muneesh Garg

Complete thread:

sample size for BA/BE studies drmuneesh 2008-10-18 09:17 [Regulatives / Guidelines]
- sample size for BA/BE studies shankar 2008-10-18 11:47
  - sample size for BA/BE studies drmuneesh 2008-10-18 12:18
    - sample size for BA/BE studies Ohlbe 2008-10-18 13:32
      - sample size for BA/BE studies drmuneesh 2008-10-19 10:42
      - sample size for BA/BE studies drmuneesh 2008-11-17 14:10
        
        sample size for BA/BE studies ElMaestro 2008-11-17 14:32
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:34
        sample size for BA/BE studies drmuneesh 2008-11-28 07:50
        
        sample size for BA/BE studies Helmut 2008-11-17 15:47
        
        sample size for BA/BE studies drmuneesh 2008-11-18 07:44
        
        sample size for BA/BE studies ElMaestro 2008-11-18 08:49
        
        sample size for BA/BE studies drmuneesh 2008-11-18 09:31
        
        sample size for BA/BE studies ElMaestro 2008-11-18 09:59
        
        sample size for BA/BE studies drmuneesh 2008-11-18 10:27
        
        sample size for BA/BE studies drmuneesh 2008-11-19 10:14
        
        sample size for BA/BE studies ElMaestro 2008-11-19 10:48
        
        sample size for BA/BE studies drmuneesh 2008-11-20 08:30
        
        CVintra # CVinter # CVtotal Helmut 2008-11-20 11:18
        
        Circulus vitiosus d_labes 2008-11-20 13:57
        
        Sterne! Helmut 2008-11-20 18:11
        
        CVintra # CVinter # CVtotaldrmuneesh 2008-11-28 10:37
        
        CVintra # CVinter # CVtotal Helmut 2008-11-29 10:14
        
        CVintra # CVinter # CVtotal drmuneesh 2008-11-30 07:18
        
        is something fishy in case 2? ElMaestro 2008-11-29 15:42
        
        is something fishy in case 2? drmuneesh 2008-11-30 07:17
        
        SAS and sample size d_labes 2008-11-19 11:33
        
        SAS and sample size drmuneesh 2008-11-20 08:31