Bioequivalence and Bioavailability Forum

Dear All,

Kindly advice what to do with following cases in one of the prazole group. This is going to be submitted in US FDA.

1. 13 out of 52 PK profiles are having 2 or less measurable concentrations for the test treatment.
   
2. 25 out of 104 PK profiles are having 2 or less measurable concentrations for the reference treatment.
   
3. 23 out of 52 PK profiles are having first measurable point as Cmax (not first point Cmax) for the test product.
   
4. 46 out of 104 PK profiles are having first measurable point as Cmax for the reference product.

Let me clear you that the study is passing but we are worried about above mentioned case. kindly advice how to handle this and how the regulatory take this.

regards,

Auditor

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Edit: Category changed. [Helmut]