Use of Model-Informed Drug Development to Streamline Development of Long-Acting Products: Can These Successes Be Translated to Long-Acting Hormonal Contraceptives?

Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients’ access to these may translate into fewer unintended pregnancies and lead substantial individual public health benefits. However, development of long-acting products can be complex challenging. This review provides ( a) an overview representative programs for antipsychotics as cases conceptual translation contraceptives, b) several case examples on how modeling simulation have been used streamline products, c) challenges andopportunities in developing information exposure-response relationships commonly progestins enable regulators developers rely prior findings effectiveness safety from approved contraceptives. The US Food Drug Administration is seeking assistance stakeholders provide data studies which pharmacokinetic pharmacodynamic or clinical outcomes hormonal were evaluated not previously submitted.