Bioequivalence and Bioavailability Forum • ∆ <5% ⇒ T/R 95%

∆ <5% ⇒ T/R 95% [Regulatives / Guidelines]

posted by nlpati – India, 2013-10-11 06:37 (4644 d 13:23 ago) – Posting: # 11649
Views: 10,137

❝ Even if the assayed contents differ by less than 5%, don’t take this value as the “truth”. The analytical method has limited accuracy/precision. For anything <5% I would still assume a T/R-ratio of 95%.

Dear Sir,

We are using formula for calculation of this value is this the right one.

Formula is (difference between assay value of test and reference / assay value of reference) X 100

Is this formula required for afore said difference calculation.

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 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