Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

Abstract

Regulatory science is science and research intended to improve decision making in a regulatory framework. Improvements in decision making can be in both accuracy (making better decisions) and in efficiency (making faster decisions). Science and research supported by the Generic Drug User Fee Amendments of 2012 (GDUFA) have focused on two innovative methodologies that work together to enable new approaches to development and review of generic drugs: quantitative models and advanced in vitro product characterization. Quantitative models faithfully represent current scientific understanding. They are tools pharmaceutical scientists and clinical pharmacologists use for making better and faster product development decisions. Advances in the in vitro product comparisons provide the measurements of product differences that are the critical input into the models. This paper outlines four areas where science and research funded by GDUFA support synergistic use of models and characterization at critical decision points during generic drug product development and review.

Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen

“…Science that supports regulatory initiatives such as the US Generic Drug User Fee Amendments focus on advanced in vitro product characterization and quantitative modeling. 31,32 For orally administered drug products, in vivo predictive dissolution testing is fundamental to inform physiologically based absorption models aimed at comparing different formulations. In this regard, integrating P-PSD and the possibility of a self-buffering effect of the drug under the overarching umbrella of physiologically based modeling appears to be a promising translational strategy to support the development of orally administered drug products containing ibuprofen and other BCS II drugs with similar properties, specially in the realm of generics.…”

Model‐Informed Drug Development for Long‐Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium

“…M&S also can be used to identify adequate PK sampling times, to determine sample size, and to support innovative and efficient BE study designs. 16,17,26,27,[29][30][31][32][33]…”

Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

“…In putting this issue together, we have attempted to cover the very large waterfront of regulatory science, ranging from biomarker validation to novel approaches and acceptability of generation of clinical evidence and regulatory licensure frameworks that now include patient‐focused drug development . We also include regulatory science topics that can improve the effectiveness and efficiency of postmarketing pharmacovigilance, generic drug approval, and strategies to facilitate demonstration of value to support reimbursement . We include topics of global import to demonstrate the impact of geopolitical forces on drug regulation, including Brexit and harmonization of regulatory requirements …”