Bioequivalence and Bioavailability Forum

Dear all,

I have some queries regarding the Bioequivalence study of a parenteral drug (Iron Sucrose Injection 20 mg/ml).

In this study 5 ml of 20 mg/ml injection will be administered undiluted as a slow intravenous injection through an indwelling cannula over a period of 5 minutes.

I need your guidance regarding the Non-compartmental model (IV bolus model or IV infusion model) to be used in WinNonlin for estimation of Pharmacokinetic Parameters which are mentioned below:
Primary Parameters: C_max (ng/mL), AUC_0-t (ng·hr/mL), AUC_0-inf (ng·hr/mL)
Secondary Parameters: T_max (min), K_el (hr^-1), t_1/2 (hr), V_c (L), V_ss (L), CL (L/hr)

I would highly appreciate your response regarding the same

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Edit: Category changed. [Helmut]