Bioequivalence and Bioavailability Forum

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

posted by mittyri – Russia, 2014-03-14 15:31 (4130 d 18:22 ago) – Posting: # 12626
Views: 7,592

Dear Helmut,

Thank you for the explanation!

❝ If I have information about a larger deviation from a pilot study I use it.

Do you insert any links to the publications about these pilot studies (may be for another market)?
Would you rest the T/R Ratio in the protocol without explanation?
Is it important to the Assessor to know - where do you get this ratio or why are you assuming such ratio?

—
Kind regards,
Mittyri

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 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 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 Protocolmittyri 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]