Bioequivalence and Bioavailability Forum • Optimism

Optimism [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-10-14 19:50 (4630 d 05:28 ago) – Posting: # 11662
Views: 10,048

Hi John,

❝ Yes but we usually only have one number (don't present SD or range) on the CofAs (test and ref)

Correct. You could ask the lab for the accuracy/precision of the method. In my previous post I only wanted to wave the warning flag concerning overly optimistic assumptions like “Hey, the difference is just 2%, let’s estimate the sample size based on a ratio of 98%”…

I’m not a pessimist,
I’m just a well informed optimist. (José Saramago)

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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
      - OptimismHelmut 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