Bioequivalence and Bioavailability Forum

the basis of T/R in the Protocol [Regulatives / Guidelines]

posted by mittyri – Russia, 2014-03-14 09:10 (4488 d 05:58 ago) – Posting: # 12620
Views: 9,007

Hi Helmut and 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.

❝ The former. Although with another reference product the ratio might be better, without a pilot study I would suggest a conservative approach.

Do you state in the protocol the reasons why did you choose the exact T/R ratio (not default 95% setting)?

—
Kind regards,
Mittyri

Complete thread:

Difference between test and reference nlpati 2013-10-10 13:40
- 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 estimation kumarnaidu 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 Protocolmittyri 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

the basis of T/R in the Pro­tocol [Regulatives / Guidelines]

Complete thread:

the basis of T/R in the Protocol [Regulatives / Guidelines]