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RegisterReplicate instead of Xover [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2015-01-02 00:07 (4195 d 00:32 ago) – Posting: # 14209
Views: 4,321
Hi Angus,
Correct. But that’s a trivial statement, right? According to FDA’s practice (for years!) one can always perform a replicate study instead of simple cross-over.
❝ […] the sponsor is given the option of running Single-dose, two-treatment, four-period, two-sequence, fully replicated crossover study in vivo.
Correct. But that’s a trivial statement, right? According to FDA’s practice (for years!) one can always perform a replicate study instead of simple cross-over.
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Helmut Schütz
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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:
- FDA: Draft guidance MPH suspension Helmut 2014-12-31 13:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: Draft guidance MPH suspension AngusMcLean 2015-01-01 21:25
- Replicate instead of XoverHelmut 2015-01-01 23:07
- Replicate instead of Xover AngusMcLean 2015-01-02 00:22
- Replicate instead of Xover Helmut 2015-01-02 01:11
- Replicate instead of Xover AngusMcLean 2015-01-02 00:22
- Replicate instead of XoverHelmut 2015-01-01 23:07
- FDA: Draft guidance MPH suspension AngusMcLean 2015-01-01 21:25
Ing. Helmut Schütz