Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval—A Case Study Using Levonorgestrel

Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval—A Case Study Using Levonorgestrel

Background: The development of long-acting products of a characterized drug substance is of great interest. It is possible to support the development of these products with available clinical data by matching the exposure to a predefined bracket of a minimal concentration for efficacy and a maximal...

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Bibliographic Details
Main Authors: Susan Cole, Henry Pertinez, Andrew S. Butler, Essam Kerwash, Swati Bhat, Eman El-Khateeb, Andrew Owen
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Pharmaceuticals
Subjects:
contraceptives
long-acting
exposure response
PBPK
Online Access:https://www.mdpi.com/1424-8247/17/12/1640
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