Bioequivalence and Bioavailability Forum

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

posted by Helmut – Vienna, Austria, 2014-03-14 16:01 (4491 d 06:15 ago) – Posting: # 12629
Views: 9,140

Hi Mittyri,

❝ ❝ 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)?

By “pilot” I meant studies the sponsor performed or have access to in an acquired dossier. Only such studies can be assesses for the quality of data (clinical performance, bioanalytics, …). Studies from the literature should be used with caution.

❝ Would you rest the T/R Ratio in the protocol without explanation?

No.

❝ Is it important to the Assessor to know - where do you get this ratio or why are you assuming such ratio?

I think we have to distinguish between assessing the protocol (authority, IEC)* and the report.

The former is much more important – especially from an ethical perspective. Only if you give all the data which led you to your decision about the sample size, the IEC could justify whether the study is ethically acceptable.
Once the study passes BE, all assumptions in the protocol are not relevant any more (therefore, post hoc power is nonsense).

Once the Austrian agency AGES did not like the sample size we stated in the protocol: “It is not acceptable to perform the study in only 16 subjects when most of the BE studies of XYZ are performed in more than 30.” Hey, it was a pilot study… Case closed.

—
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
- 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 ProtocolHelmut 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]