Bioequivalence and Bioavailability Forum • Assayed content

Assayed content [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-10-10 16:46 (4638 d 00:03 ago) – Posting: # 11642
Views: 10,173

Namaste Lakshmi,

❝ Dear Sir,

▲ Not interested in opinions of the female members of the forum?

❝ […] "The drug content of the test product cannot differ from that of the reference listed product by more than 5 percent". […] if there is any formula for finding the difference or is it only difference between assay values of test and reference.

Only the latter.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Difference between test and reference nlpati 2013-10-10 13:40 [Regulatives / Guidelines]
- Assayed contentHelmut 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