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RegisterWashout period from pilot study [Design Issues]
Dear group
we did a pilot study for a drug whose t1/2 of the innovator is 16-25hrs.but in our pilot study we got a t1/2 of 63-70 hrs for both test and reference formulations.so, now when calculating sampling points and washout period for Pivotal study,which data should we consider?-pilot's or original from package insert?
we did a pilot study for a drug whose t1/2 of the innovator is 16-25hrs.but in our pilot study we got a t1/2 of 63-70 hrs for both test and reference formulations.so, now when calculating sampling points and washout period for Pivotal study,which data should we consider?-pilot's or original from package insert?
Complete thread:
- Washout period from pilot studyvelupharm 2006-09-04 06:43
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- Washout period from pilot study Helmut 2006-09-07 12:08
- Washout period from pilot study velupharm 2006-09-08 07:33
- Washout period from pilot study ghouse1111 2006-12-17 08:30
- off-topic (Netiquette) Jaime_R 2006-12-18 00:54
- Washout period from pilot study Helmut 2006-09-07 12:08
Ing. Helmut Schütz