Butler AS

ORCID: 0000-0003-4362-940X · 1 paper in corpus

2024

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

Pharmaceuticals (Basel, Switzerland) ·doi:10.3390/ph17121640

BackgroundThe 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 brac…