Journal
ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 61, 2021
Volume 61, Issue -, Pages 745-756Publisher
ANNUAL REVIEWS
DOI: 10.1146/annurev-pharmtox-031120-015212
Keywords
long-acting contraceptive; long-acting injectable antipsychotics; modeling and simulation; exposure-response; drug development
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Long-acting contraceptives are the most effective reversible contraceptive methods, leading to fewer unintended pregnancies and significant individual and public health benefits. However, developing long-acting products can be complex and challenging, requiring reliance on prior research data to streamline the development process.
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 (a) an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, (b) several case examples on how modeling and simulation have been used to streamline the development of long-acting products, and (c) examples of challenges and opportunities 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.
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