CL and Vd calculations in WinNonlin [Software]

posted by kumarnaidu – Mumbai, India, 2014-07-11 09:29 (3938 d 02:42 ago) – Posting: # 13257
Views: 10,952

Hello all,
I have a questions regarding calculation of volume of distribution and clearance for single dose of Amphotericin B injection. Study design is open label, randomized, two-treatment, two period, two-sequence, single dose, crossover, comparative pharmacokinetic study in healthy adult human subjects under fed conditions.
Dose mode of administration is single dose of Amphotericin B liposome for injection (3 mg/kg body weight). Dose was given to subjects with respective subject weight
i.e. suppose subject No.01, weight 73 and dose 3mg/kg then total dose= 73 kg * 3 mg/kg =219 mg.
I had calculated administration VD and CL based on the non-compartmental model using IV infusion dose type. Following information’s was provided in dosing sheet in winNonlin software.

sub-1, period-1, dose-219mg, time of dose-0,
Length of Infusion-2

sub-1, period-2, dose-219mg, time of dose-0,
Length of Infusion-2.01

PK parameter calculations VD and CL values obtained from winNonlin were not matching with reference article

WinNonlin results of VD and CL is as below

Sub  VD (mL)   CL (mL/hr)
1    29759.19  833.3955
1    82120.74  1029.759


sub-1, period-1, VD (mL)-29759.19, CL (mL/hr)-833.3955
sub-1, period-2, VD (mL)-82120.74, CL (mL/hr)-1029.759

Could anyone please guide me how to estimate VD and CL in mL/kg and mL/hr/kg in winNonlin software. Is there any option available to find out VD and CL in mL/kg and mL/hr/kg.

Thanks in advance


Edit: Unlinked from this post, category changed. [Helmut]

Kumar Naidu

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