Bioequivalence and Bioavailability Forum

Reference scaled approach for HVD [RSABE / ABEL]

posted by KR – India, 2009-02-07 12:29 (5918 d 21:19 ago) – Posting: # 3197
Views: 18,865

Dear all,
I have some confusion regarding statistical analysis of highly variable drug like lansoprazole which are mentioned below:

1. Sample size: how can we calculate sample size as we do not have any in-house study data of partial/full replicate data? Can anyone suggest me the procedure for sample size for highly variable drug (HVD) using reference scale approach. Can we use the data of two way crossover for sample size calculation in such case?
   
2. Bioequivalence criteria: How and when to decide bioequivalence limits of HVD using reference scale for a new study? i.e after statistical analysis of the study or should be pre-defined in the protocol. How to mention the criteria in the protocol?
   
3. Statistical analysis: How to do statistical analysis using reference scale?

Waiting for your valuable reply,

Thanks and regards,

KR

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Edit: Category changed. Maybe you consider using a different name in your signature; 'Dear KR' in a reply would sound strange to me.. [Helmut]

Complete thread:

• Reference scaled approach for HVDKR 2009-02-07 11:29 [RSABE / ABEL] 
  • Reference scaled approach for HVD Helmut 2009-02-07 15:58
    • Reference scaled approach for HVD d_labes 2009-02-09 11:26
      • Reference scaled approach for HVD ddubins 2009-03-12 03:34
        • Estimated knowledge d_labes 2009-03-12 14:55
          • Estimated knowledge sdu 2010-01-26 21:21
            • SABE issues d_labes 2010-01-27 14:00
    • Reference scaled approach for HVD BE 2009-03-19 12:30
  • Reference scaled approach for HVD MGR 2009-04-01 07:59