Certara UK Limited Simcyp Division, Sheffield, UK.
Certara Integrated Drug Development, Oss, The Netherlands.
CPT Pharmacometrics Syst Pharmacol. 2021 Sep;10(9):967-972. doi: 10.1002/psp4.12678. Epub 2021 Jul 20.
Pediatric physiologically-based pharmacokinetic (PBPK) models have broad application in the drug development process and are being used not only to project doses for clinical trials but increasingly to replace clinical studies. However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidance on pediatrics. Best practice standards are presented for further development through interaction among regulators, industry, and model providers.
儿科生理药代动力学（PBPK）模型在药物开发过程中有广泛的应用，不仅用于预测临床试验剂量，而且越来越多地用于替代临床研究。然而，该方法尚未完全纳入监管申报。新出现的数据支持在儿科监管指南中更广泛地纳入基于 PBPK 模型的信息方法。通过监管机构、行业和模型提供者之间的相互作用，提出了最佳实践标准，以进一步发展。
