Bioequivalence and Bioavailability Forum

Dear Helmut,
Thanks for the response. I have used winNonlin 6.3 version for PK calculations.
(Reference article values of Vd and CL) The pharmacokinetic parameters of total amphotericin B (mean ± SD) after the first dose and at steady state are shown in the table below.

I used dosing information in winNonlin i.e., 219 000 ug instead of 219 mg. In the NCA- setup select Norma­li­zation and kg is worked, I found unit correctly but still Cl and Vd values were not matches with reference article. After dose conversions I got same results

WinNonlin result of Vd and Cl is as below:

Subject Period VZ (mL/kg) CL(ml/hr/Kg)
   1      1     29759.19    833.39545
   1      2     82120.74   1029.7594

Reference: Prescribing information of AmBisome® (amphotericin B) liposome for injection from Astellas Pharma US, Inc. [cited 18 December, 2013]. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050740s021lbl.pdf




Regards