定量药理学与儿童药物研发和合理用药

中国临床药理学与治疗学 ›› 2010, Vol. 15 ›› Issue (1): 1-10.

• 专论 • 下一篇

定量药理学与儿童药物研发和合理用药

史军¹, Jeffrey S.Barrett²

¹Daiichi-Sankyo Pharma Development, Edison, NJ 08837, USA;
²The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA

收稿日期:2009-12-12 修回日期:2010-01-05 出版日期:2010-01-26 发布日期:2020-09-21
作者简介:史军, 医学博士, 现任Allergan临床药理和定量科学部科技主任, 美国学院临床药理学院士(FCP)和美国临床药理学和治疗学资深会员, 群体药动药效学专家。Jeffrey S.Barrett, 博士, 宾夕凡尼亚州大学儿科学研究副教授, 费城儿童医院临床药理学与治疗学部应用药动药效学实验室主任, 宾夕凡尼亚州大学临床流行病学与生物统计学中心副研究员。

Pharmacometrics in pediatric drug development and rational dosage

SHI Jun¹, Jeffrey S.Barrett²

¹Daiichi-Sankyo Pharma Development, Edison, NJ 08837, USA;
²The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA

Received:2009-12-12 Revised:2010-01-05 Online:2010-01-26 Published:2020-09-21

摘要/Abstract

Abstract: This article provides a comprehensive overview of key issues related to pediatric drug development and rational dosing guidance in pediatrics with an emphasis on how pharmacometrics can improve the efficiency and productivity of pediatric trials. The pharmacokinetics (PK) and pharmacodynamics (PD) of drugs are often different between adult and pediatric populationns which necessitate specific studies in children.The aims of this review are to discuss a number of recent methodological developments of modeling and simulation that facilitate the evaluation of drugs in pediatrics.Specific focus has been placed on addressing the key issues of PK/PD scaling, sparse sampling, colinearity, covariate evaluation, dose optimization for trial design and label, modeling strategies and validation approaches.The features and potent ial advantages of Bayesian hierarchical model, physiology-based PK models, and K-PD models are also presented.

Key words: Pediatric trials, Pharmacometrics, Sparse sampling, Modeling and simulation, Bayesian hierarchical model

史军, Jeffrey S.Barrett. 定量药理学与儿童药物研发和合理用药[J]. 中国临床药理学与治疗学, 2010, 15(1): 1-10.

SHI Jun, Jeffrey S .Barrett. Pharmacometrics in pediatric drug development and rational dosage[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(1): 1-10.

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定量药理学与儿童药物研发和合理用药

Pharmacometrics in pediatric drug development and rational dosage

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