Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA; email:
Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Annu Rev Pharmacol Toxicol. 2021 Jan 6;61:745-756. doi: 10.1146/annurev-pharmtox-031120-015212. Epub 2020 Sep 30.
Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients' access to these contraceptives may translate into fewer unintended pregnancies and lead to substantial individual and public health benefits. However, development of long-acting products can be complex and challenging. This review provides () an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, () several case examples on how modeling and simulation have been used to streamline the development of long-acting products, and () examples of challenges andopportunities in developing long-acting contraceptives and information on how exposure-response relationships of commonly used progestins may enable regulators and developers to rely on prior findings of effectiveness and safety from an approved contraceptive to streamline the development of long-acting contraceptives. The US Food and Drug Administration is seeking assistance from stakeholders to provide data from studies in which pharmacokinetic and pharmacodynamic or clinical outcomes of hormonal contraceptives were evaluated and not previously submitted.
长效避孕药是最有效的可逆避孕方法。增加患者对这些避孕药的可及性可能会减少意外怀孕，并带来显著的个人和公共健康益处。然而，长效产品的开发可能很复杂且具有挑战性。本综述提供了（）长效抗精神病药代表性开发项目的概述，作为将概念转化为长效避孕药的案例，（）如何使用建模和模拟来简化长效产品开发的几个案例示例，以及（）开发长效避孕药面临的挑战和机遇的示例，以及关于常用孕激素的暴露-反应关系如何使监管机构和开发人员能够依靠已批准避孕药的有效性和安全性的现有发现来简化长效避孕药的开发的信息。美国食品和药物管理局正在寻求利益相关者的协助，提供以前未提交的评估激素避孕药药代动力学和药效学或临床结果的研究数据。
