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Dear All,
Is there any regularity guidline about How to access the dose proportionality in a parallel and crossover biostudy?
We have just conducted a Parallel, 1 period, three treatment, single dose, investigational pilot study on 18 healthy volunteers. Treatments which were used in this study were (1). Test1 (one 100mg tablet of drug X), (2). Test2 (Two 100mg tablets of drug X), (3). Test3 (No tablet or drug X was given). Group receving Test3 is considered as a control group.
Is it possible to access dose proportionality in this type of study. If yes please give me some detail about how to access dose proportionality in this study.
Waiting for your valuable suggestion.
Is there any regularity guidline about How to access the dose proportionality in a parallel and crossover biostudy?
We have just conducted a Parallel, 1 period, three treatment, single dose, investigational pilot study on 18 healthy volunteers. Treatments which were used in this study were (1). Test1 (one 100mg tablet of drug X), (2). Test2 (Two 100mg tablets of drug X), (3). Test3 (No tablet or drug X was given). Group receving Test3 is considered as a control group.
Is it possible to access dose proportionality in this type of study. If yes please give me some detail about how to access dose proportionality in this study.
Waiting for your valuable suggestion.
—
Thanks & Regards
Ravi Pandey
Thanks & Regards
Ravi Pandey
Complete thread:
- Dose proportionalityRavi 2009-05-15 07:43 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dose proportionality Helmut 2009-05-16 00:44
- ratio of dose-adjusted AUCs martin 2009-05-16 11:33
- ratio of dose-adjusted AUCs Helmut 2009-05-16 16:24
- ratio of dose-adjusted AUCs martin 2009-05-16 11:33
- Dose proportionality Helmut 2009-05-16 00:44
Ing. Helmut Schütz