Bioequivalence and Bioavailability Forum • Hospitalization of volunteers

Hospitalization of volunteers [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2011-03-05 13:38 (5596 d 01:21 ago) – Posting: # 6709
Views: 2,638

Dear Manan!

❝ [...] we can have in place some tests (like breath tests for alcohol and smoking tests) with which we can confirm that subjects have not violated any restrictions.

❝

❝ I think having such tests in place can give accurate results.

Yes, these test are reliable. But you cannot check “violation of any restrictions”. See your previous post:

❝ ❝ [...] check whether the subjects has not consumed any unsual diet or have

❝ ❝ followed the restrictions to be observed during the trial so that the PK

❝ ❝ profile is not altered.

Diet? Intake of drugs? Both can alter the elimination (think about grapefruit juice, PK interactions). Attending a triathlon (aka strenous physical activity)? How could you confirm any of these? IMHO you would solely have to rely on asking them – and the answer is obvious.

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Helmut Schütz

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Complete thread:

Hospitalization of volunteers konkous 2011-03-01 21:08
- Hospitalization of volunteers manan 2011-03-03 07:24
  - Hospitalization of volunteers Helmut 2011-03-03 13:39
    - Hospitalization of volunteers manan 2011-03-05 07:29
      - Hospitalization of volunteersHelmut 2011-03-05 12:38