Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval—A Case Study Using Levonorgestrel
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DOI: 10.3390/ph17121640
Abstract: 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… read more here.
Keywords: long acting; bracketing approach; development long; safety ... See more keywords