Development and verification of a pharmacokinetic model to optimize ...
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Development and verification of a pharmacokinetic model to optimize ...
Development and verification of a pharmacokinetic model to optimize physiologic replacement of rhIGF-1/rhIGFBP-3 in preterm infants Jou-Ku Chung1, Boubou Hallberg2, Ingrid Hansen-Pupp3, Martin A. Graham4, Gerald Fetterly4, Jyoti Sharma4, Adina Tocoian5, Nerissa C. Kreher1, Norman Barton1, Ann Hellström6 and David Ley3 Background: rhIGF-1/rhIGFBP-3 is being investigated for prevention of retinopathy of prematurity in extremely preterm infants. Methods: A population pharmacokinetic model was developed using data from phase I/II (Sections A–C) trials of rhIGF-1/ rhIGFBP-3 and additional studies in preterm infants to predict optimal dosing to establish/maintain serum IGF-1 within physiological intrauterine levels. In Section D of the phase II study, infants (gestational age (GA) (wk+d) 23+0 to 27+6) were randomized to rhIGF-1/rhIGFBP-3, administered at the modelpredicted dose of 250 µg/kg/d continuous i.v. infusion up to postmenstrual age (PMA) 29 wk+6 d or standard of care. An interim pharmacokinetic analysis was performed for the first 10 treated infants to verify dosing. Results: Serum IGF-1 data were reviewed for 10 treated/9 control infants. Duration of therapy in treated infants ranged 1–34.5 d. At baseline (before infusion and
