Bioequivalence and Bioavailability Forum

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

posted by Helmut – Vienna, Austria, 2014-03-15 00:02 (4130 d 22:26 ago) – Posting: # 12632
Views: 7,600

Hi Mittyri,

❝ […] you state in the protocol phrases like that:

❝ According to the earlier performed by sponsor study, T/R ratio could be assumed as 0.92%.

Something like that.

❝ How could I prove to the assessor that "pilot" study is really performed? As a sponsor I can write that I performed the study in another market, but assessment report isn't published (no links)

I never was a sponsor. When I worked for a CRO and now as a consultant I refer only to a study which was really performed (i.e., I have the synopsis / report or at least the data on my desk) and not some product of wet fantasies. I was never asked (neither by an IEC or an authority) to prove that the pilot was not a fake. However, would be easy to satisfy them.
If a sponsor gives me a number in an e-mail – and doesn’t want to show me the data – I immediately quit working for him/her/it.

❝ ❝ 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…

❝

❝ Nice example :-D

❝ In this case, did you "hit the jackpot" (by the luck CI's were in the borders)?

Can’t remember. But it was not the purpose of the study to show BE. There are many reasons to perform a pilot study (check the design, bioanalytics, the T/R, CV, …) and I’m positive that we stated all of them in the protocol. Probably the reviewer had such a “chain of command” in his mind:
BE-study ⇒ drug XYZ ⇒ most studies I have seen were performed in 32–56 subjects ⇒ the CRO wants to get a lucky punch with 16 ⇒ reject the protocol.
In Austria protocols are not approved (written stuff). The system works the other way ’round: You submit the protocol and receive a statement of receipt. This date starts the clock. If you don’t get an objection letter within four weeks, you can start the study.
It took me a three-minute phone-call to sort the “misunderstanding about the sample size” out. The reviewer suggested to throw his letter into the next wastebasket, which I did.

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Helmut Schütz

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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
      - 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 ProtocolHelmut 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]