Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval—A Case Study Using Levonorgestrel
Understanding of the exposure response is not currently considered sufficient to support a bracketing approach for a new levonorgestrel product. If additional safety data are established, current regulations may allow for a reduced application package. Additional work is needed to support the approach, and this could utilize the wealth of information in real-world datasets combined with systems models.
Authors
- Henry Pertinez
- Eman El‐Khateeb (ORCID: https://orcid.org/0000-0002-8365-6528)
- Essam Ghazaly (ORCID: https://orcid.org/0000-0003-4368-8565)
- Swati Bhat
- Andrew S. Butler (ORCID: https://orcid.org/0000-0003-4362-940X)
- Andrew Owen (ORCID: https://orcid.org/0000-0002-9819-7651)
- Susan Cole (ORCID: https://orcid.org/0000-0002-4582-6231)
Institutions
- University of Liverpool (GB)
- Tanta University (EG)
Publication Details
- Journal
- Pharmaceuticals
- Published
- 2024-12-06
- DOI
- https://doi.org/10.3390/ph17121640
- Primary Topic
- Reproductive Health and Contraception
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Bill and Melinda Gates Foundation