Exploring the Impact of Developmental Clearance Saturation on Propylene Glycol Exposure in Adults and Term Neonates Using Physiologically Based Pharmacokinetic Modeling.

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Tác giả: Karel Allegaert, Michael Garle, Robin Michelet, Olusola Olafuyi

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: England : Journal of clinical pharmacology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 729311

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Propylene glycol (PG) is a pharmaceutical excipient which is generally regarded as safe (GRAS), though clinical toxicity has been reported. PG toxicity has been attributed to accumulation due to saturation of the alcohol dehydrogenase (ADH)-mediated clearance pathway. This study aims to explore the impact of the saturation of ADH-mediated PG metabolism on its developmental clearance in adults and neonates and assess the impact of a range of doses on PG clearance saturation and toxicity. Physiologically based pharmacokinetic (PBPK) models for PG in adults and term neonates were developed using maximum velocity (V

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