| Autor: |
Denis Menshykau, Jagdev Sidhu, Laura Shaughnessy, Rocio Lledo‐Garcia, Pinky Dua, Marie Teil, Akash Khandelwal |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 11, Pp 1904-1914 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2163-8306 |
| DOI: |
10.1002/psp4.13220 |
| Popis: |
Abstract Certolizumab pegol (CZP; CIMZIA™) is the only Fc‐free tumor necrosis factor inhibitor with data from a clinical study demonstrating no to minimal placental transfer. The pharmacokinetics (PK) of certolizumab pegol during pregnancy and postpartum in women with chronic inflammatory diseases were assessed using a population PK model based on data from the CHERISH study (NCT04163016), a longitudinal, prospective, open‐label PK phase IB study. Model development was performed in NONMEM using a frequentist prior approach, with prior information based on a population PK model for certolizumab pegol in non‐pregnant adult patients (NCT04740814). A one‐compartment model with first‐order absorption (Ka = 0.236 1/day) and linear elimination (CL/F = 0.416 L/day) from the central compartment (V/F = 7.86 L) best described certolizumab pegol PK in the CHERISH study. The structural model parameters were estimated with good precision (RSE |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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