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Registerclarification on analysis for different doses [Design Issues]
Hello,
I want clarification on analysis for the following study:
We are doing pilot Bio-study on particular product. Here Reference product (15 mg) strength is double the Test product (7.5 mg). Now in clinical portion first we given both test (7.5 mg) and reference (15 mg) products according to randomization. After 8 hours again one Test product (7.5 mg) was given. Now total strengths are equal? In analysis we got 2 peaks for Test product (i.e. 1st dose and after 2nd dose). Here my doubt is that which Cmax we can take for Test product? Remaining PK parameters also how to I calculate.
Please give the reply as early as possible
Regards,
Pandu
I want clarification on analysis for the following study:
We are doing pilot Bio-study on particular product. Here Reference product (15 mg) strength is double the Test product (7.5 mg). Now in clinical portion first we given both test (7.5 mg) and reference (15 mg) products according to randomization. After 8 hours again one Test product (7.5 mg) was given. Now total strengths are equal? In analysis we got 2 peaks for Test product (i.e. 1st dose and after 2nd dose). Here my doubt is that which Cmax we can take for Test product? Remaining PK parameters also how to I calculate.
Please give the reply as early as possible
Regards,
Pandu
Complete thread:
- clarification on analysis for different dosesPandu 2008-02-25 11:52
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- clarification on analysis for different doses ShankarCL 2008-02-29 12:26
Ing. Helmut Schütz