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Hi Venu,
2x2 cross over design is a standard design. Definitely this is not the only design for BA/BE studies. You can also use replicate designs if you can justify its use. For cross over studies there are many designs.
Yes, you can use compartment models. The only reason why the guidelines insist on non-compartment models is, to use compartment models you need good expertise in pharmacokinetic principles and one should know exactly how and when to use compartmental models. One should also know then how many data points are to be used in the log-linear segment in the elimination phase based on the number of compartments one uses. This is bit complicated to non-pharmacokineticians (most CROs employ nono-pharmacokineticians to do data modeling).
Dr. Shiv
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Edit: Full quote removed. [HS]
2x2 cross over design is a standard design. Definitely this is not the only design for BA/BE studies. You can also use replicate designs if you can justify its use. For cross over studies there are many designs.
Yes, you can use compartment models. The only reason why the guidelines insist on non-compartment models is, to use compartment models you need good expertise in pharmacokinetic principles and one should know exactly how and when to use compartmental models. One should also know then how many data points are to be used in the log-linear segment in the elimination phase based on the number of compartments one uses. This is bit complicated to non-pharmacokineticians (most CROs employ nono-pharmacokineticians to do data modeling).
Dr. Shiv
--
Edit: Full quote removed. [HS]
Complete thread:
- Pharmacokinetic Models venu 2007-02-14 05:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pharmacokinetic Models vs. NCA Jaime_R 2007-02-14 11:44
- Pharmacokinetic Models vs. NCA venu 2007-02-21 04:54
- Pharmacokinetic Modelsdrshiv 2007-02-25 15:08
- Pharmacokinetic Models vs. NCA Jaime_R 2007-02-14 11:44
Ing. Helmut Schütz