Bioequivalence and Bioavailability Forum • Difference between test and reference

Difference between test and reference [Regulatives / Guidelines]

posted by nlpati – India, 2013-10-10 15:40 (4646 d 15:19 ago) – Posting: # 11641
Views: 11,203

Dear Sir,
Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations, mentions as "The drug content of the test product cannot differ from that of the reference listed product by more than 5 percent". Kindly request you to suggest that if there is any formula for finding the difference or is it only difference between assay values of test and reference.

with rgds,
Lakshmipathy

Complete thread:

Difference between test and referencenlpati 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