Bioequivalence and Bioavailability Forum • Sampling time deviations

Sampling time deviations [Regulatives / Guidelines]

posted by Ohlbe – France, 2010-09-02 12:25 (5764 d 14:20 ago) – Posting: # 5874
Views: 4,424

Dear Thirupathi,

There are two different aspects that should not be mixed up:

first, is a sampling time deviation a protocol deviation. If you define a 30 minute window in your protocol, sampling time deviations of less than 30 minutes are not protocol deviations, but sampling time deviations of more than 30 minutes will be considered as protocol deviations and would need to be reported in that section of the trial report;
second, should sampling time deviations be considered for AUC calculations. The new EMA guideline is clear (§ 4.1.5, Pharmacokinetic parameters):
Actual time of sampling should be used in the estimation of the pharmacokinetic parameters
My interpretation of this would be that if a sample was taken at 48 hours and 30 minutes, the sampling time should be considered to be 48.5 and not 48, even if it is still within the 30-minute window defined in your protocol.

Regards
Ohlbe

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Regards
Ohlbe

ambulatory sample thirupathireddy alla 2010-09-02 06:36 [Regulatives / Guidelines]
- Sampling time deviationsOhlbe 2010-09-02 10:25
- ambulatory sample Helmut 2010-09-02 12:46
  - ambulatory sample thirupathireddy alla 2010-09-03 13:33
    - ambulatory sample patilatu 2010-09-22 06:57