Bioequivalence and Bioavailability Forum • T/R 90% to 110% for sample size estimation

T/R 90% to 110% for sample size estimation [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2013-11-26 06:36 (4585 d 17:40 ago) – Posting: # 11969
Views: 9,861
(edited on 2013-11-26 11:08)

Dear all,
If in my earlier studies I am getting T/R ratio= 110% means >5% difference then for planning another study for another market should I go with the T/R=110% or 95% for sample size estimation.

As per EMA guideline (2010) "batches should not differ more than 5%" so taking 10% difference in T/R ratio is considerable.

Also if I am taking the T/R ratio=110% I am getting sample size around 50 (without dropout) but many studies I found for this drug is around 40 even our earlier study had 42. then in that case if am exceeding sample size will it considered as a forced bioequivalence?

Earlier study results used for sample size estimation
LnCmax ratio=110.3 (90%CI- 101.06-120.54) CV=24.3.

Please reply.

—
Kumar Naidu

Complete thread:

Difference between test and reference nlpati 2013-10-10 13:40 [Regulatives / Guidelines]
- Assayed content Helmut 2013-10-10 14:46
- Difference between test and reference jag009 2013-10-10 15:19
  - ∆ <5% ⇒ T/R 95% Helmut 2013-10-10 16:08
    - ∆ <5% ⇒ T/R 95% nlpati 2013-10-11 04:37
    - ∆ <5% ⇒ T/R 95% jag009 2013-10-13 21:02
      - Optimism Helmut 2013-10-14 17:50
        
        T/R 90% to 110% for sample size estimationkumarnaidu 2013-11-26 05:36
        
        T/R 110% Helmut 2013-11-30 14:02
        
        T/R 110% kumarnaidu 2013-12-02 05:35
        the basis of T/R in the Protocol mittyri 2014-03-14 08:10
        
        the basis of T/R in the Protocol Helmut 2014-03-14 13:53
        
        the basis of T/R in the Protocol mittyri 2014-03-14 14:31
        
        the basis of T/R in the Protocol Helmut 2014-03-14 15:01
        
        the basis of T/R in the Protocol mittyri 2014-03-14 21:08
        
        the basis of T/R in the Protocol Helmut 2014-03-14 23:02