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RegisterSteady State Bioequivalence Study [Design Issues]
Hello All,
A case of Steady state bioequivalence study in which dose is administered twice daily from Day XX to Day XX. Suppose Day 01 to Day 07 where on day 07 only morning dose will be administered. My question is what is the ideal pre-dose time points required to collect to get Cpd. As per guideline, at least 3 pre-dose samples are required to collect. But as we are administrating Drug twice daily, its is necessary to collect pre-dose for morning and evening both for few days i.e Day 01 (morning evening), Day 04 (morning evening) and Day 07 (Morning)?
Also suggest for t.i.d. administration.
Appreciate your valuable suggestion in this regards.
Edit: Category changed; see also this post #1. [Helmut]
A case of Steady state bioequivalence study in which dose is administered twice daily from Day XX to Day XX. Suppose Day 01 to Day 07 where on day 07 only morning dose will be administered. My question is what is the ideal pre-dose time points required to collect to get Cpd. As per guideline, at least 3 pre-dose samples are required to collect. But as we are administrating Drug twice daily, its is necessary to collect pre-dose for morning and evening both for few days i.e Day 01 (morning evening), Day 04 (morning evening) and Day 07 (Morning)?
Also suggest for t.i.d. administration.
Appreciate your valuable suggestion in this regards.
Edit: Category changed; see also this post #1. [Helmut]
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Regards,
Pharma_88
Regards,
Pharma_88
Complete thread:
- Steady State Bioequivalence StudyPharma_88 2020-01-08 10:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pre-dose samples Helmut 2020-01-09 12:36
- Study design multiple dose stuy - circadian PK Summertime 2020-03-26 17:29
- Pre-dose samples Helmut 2020-01-09 12:36
Ing. Helmut Schütz