Precision Biopharmaceutics: An Organizational and Analytical Framework Against Sex Bias in Research and Development
Progress toward precision medicine is currently bottlenecked by a structural androcentric bias in the preclinical and clinical phases of biopharmaceutical research. This paper proposes an original cross-disciplinary conceptual framework that unifies the biophysical models of compartmental pharmacokinetics with contemporary theories of Organizational Development and People Analytics. Through the mathematical formalization of the Methodological Diversity Index (MDI) and the design of a molecular-organizational intervention taxonomy, this manuscript transcends a simple literature review to establish a scientifically grounded methodological guide. The objective is to offer an operational and algorithmic matrix indispensable for mitigating the late-stage attrition rate in the drug product pipeline and optimizing post-marketing clinical safety within the female population.
Authors
- Emily Madelaine Sisalima Maldonado (ORCID: https://orcid.org/0009-0004-3098-7333)
Institutions
- Universidad Tecnica de Machala (EC)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2026-06-09
- DOI
- https://doi.org/10.5281/zenodo.20602307
- Primary Topic
- Sex and Gender in Healthcare
- Type
- preprint