Bioequivalence and Bioavailability Forum • clarification on analysis for different doses

Pandu
★

India,
2008-02-25 12:52
(6694 d 18:05 ago)

Posting: # 1629
Views: 3,419

clarification 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

ShankarCL
●

2008-02-29 13:26
(6690 d 17:30 ago)

@ Pandu
Posting: # 1646
Views: 2,671

clarification on analysis for different doses

Post reply

Dear Pandu,

Please be clear of the aim of your study. Were the test products of different batches (as would be for a comparative BA study with different dosage). Then you could take individual Cmax of both test products and compare it with the reference to know the proportion, if it was your indended aim.

If you intended to determine the BE then I am afraid you did the wrong dosing, as you know that both units of tests should be dosed simultaneously. Hope I could clarify.