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- W3009296923 abstract "• We evaluated the PK of an IgG (Gammagard) in very low birth weight neonates. • Our evaluation was based on baseline-corrected and uncorrected IgG serum concentrations. • The two methods of PK evaluation gave different PK parameter estimates. • The PK of Gammagard was substantially different in neonates than adults (historical comparison). • The dose of IgGs should be adjusted based on the PK of baseline corrected profiles. Immunoglobulins are widely used across multiple therapeutic areas such as immunodeficiency syndromes, infection and autoimmune diseases. The pharmacokinetics (PK) of immunoglobulins are well characterized in adults, but very little is known about the PK of immunoglobulins in neonates and infants. The objective of the present study was to characterize the PK of Gammagard, an immunoglobulin, in very low birth weight preterm neonates. Gammagard concentration-time data from very low birth weight neonates (bodyweight range 0.78–1.38 kg, n = 20) following intravenous administration of 500 mg/kg and 750 mg/kg were obtained from the literature. The data were analyzed with and without baseline correction using extensive blood samples (8 blood samples). Model-independent (non-compartmental) analysis was used to characterize the PK of Gammagard. Based on uncorrected baseline concentration-time data, the clearance and half-life of Gammagard were 3.1 ± 0.7 mL/day and 22 ± 6 days, respectively. Based on corrected baseline concentration-time data, the clearance and half-life of Gammagard were 20.2 ± 7.4 mL/day and 5.3 ± 2.2 days, respectively. The dose of immunoglobulins should be adjusted based on the PK of baseline corrected rather than baseline uncorrected profiles because baseline corrected PK parameters especially half-life reconciles with PK principles." @default.
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- W3009296923 date "2020-05-01" @default.
- W3009296923 modified "2023-10-18" @default.
- W3009296923 title "Considerations for pharmacokinetic assessment of immunoglobulins: Gammagard in very low birth weight neonates with and without baseline-correction" @default.
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- W3009296923 doi "https://doi.org/10.1016/j.intimp.2020.106358" @default.
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