| Autor: |
Elassaiss‐Schaap, J, Rossenu, S, Lindauer, A, Kang, SP, de Greef, R, Sachs, JR, de Alwis, DP |
| Jazyk: |
angličtina |
| Rok vydání: |
2016 |
| Předmět: |
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| Zdroj: |
CPT: Pharmacometrics & Systems Pharmacology |
| ISSN: |
2163-8306 |
| Popis: |
Evaluation of pharmacokinetic/pharmacodynamic (PK/PD) properties played an important role in the early clinical development of pembrolizumab. Because analysis of data from a traditional 3 + 3 dose‐escalation design revealed several critical uncertainties, a model‐based approach was implemented to better understand these properties. Based on anticipated scenarios for potency and PK nonlinearity, a follow‐up study was designed and thoroughly evaluated. Execution of 14,000 virtual trials led to the selection and implementation of a robust design that extended the low‐dose range by 200‐fold. Modeling of the resulting data demonstrated that pembrolizumab PKs are nonlinear at |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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