A User-Driven Framework for Dose Selection in Pregnancy: Proof of Concept for Sertraline.

IF 6.3 2区 医学 Q1 PHARMACOLOGY & PHARMACY Clinical Pharmacology & Therapeutics Pub Date : 2024-09-09 DOI:10.1002/cpt.3429
Charlotte Koldeweij, Caroline Dibbets, Bryony D Franklin, Hubertina C J Scheepers, Saskia N de Wildt
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Abstract

Despite growing knowledge of pregnancy-induced changes in physiology that may alter maternal and fetal pharmacokinetics, evidence-based antenatal doses are lacking for most drugs. Pharmacokinetic modeling and expanding clinical data in pregnancy may support antenatal doses. We aimed to develop and pilot a comprehensive and user-driven Framework for Dose Selection in Pregnancy to support the clinical implementation of a best-evidence antenatal dose for sertraline. After initial development and evaluation by experts, the framework prototype was piloted to formulate an antenatal dosing strategy for sertraline in depression and anxiety disorders. Next, the framework was reviewed and assessed for usability by a multidisciplinary working committee of end-users comprising healthcare practitioners, experts from other disciplines including pharmacometrics, reproductive toxicology and medical ethics, alongside pregnant women and a partner. The resulting framework encompasses the following: rationale for drug selection, a comprehensive analysis of pharmacokinetic and dose-related efficacy and safety data, and implementation aspects including feasibility and desirability of the recommended antenatal dose based on a structured maternal and fetal benefit-risk assessment. An antenatal dose recommendation for sertraline, as a case study, was formulated using this approach and endorsed for clinical use by the working committee. Future applications of the framework for other drugs can further demonstrate its suitability for developing best evidence, acceptable and clinically feasible antenatal doses.

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用户驱动的妊娠期剂量选择框架:舍曲林的概念验证。
尽管人们对妊娠引起的生理变化有了越来越多的了解,这些变化可能会改变母体和胎儿的药代动力学,但大多数药物都缺乏以证据为基础的产前剂量。妊娠期药代动力学建模和不断扩大的临床数据可为产前剂量提供支持。我们旨在开发并试行一个全面的、用户驱动的妊娠期剂量选择框架,以支持舍曲林最佳循证产前剂量的临床实施。经过专家的初步开发和评估后,我们对该框架原型进行了试用,以制定抑郁症和焦虑症患者舍曲林的产前剂量策略。接下来,由医疗保健从业人员、药物计量学、生殖毒理学和医学伦理学等其他学科的专家以及孕妇和一名伴侣组成的最终用户多学科工作委员会对该框架进行了审查和可用性评估。最终形成的框架包括以下内容:药物选择的基本原理、药代动力学和剂量相关的疗效和安全性数据的综合分析,以及实施方面的内容,包括根据结构化的孕产妇和胎儿获益风险评估所推荐的产前剂量的可行性和可取性。以舍曲林为例,我们采用这种方法制定了产前剂量建议,并得到了工作委员会的认可,可用于临床。未来将该框架应用于其他药物,可进一步证明其适用于制定最佳证据、可接受且临床可行的产前剂量。
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来源期刊
CiteScore
12.70
自引率
7.50%
发文量
290
审稿时长
2 months
期刊介绍: Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.
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