Anticipated Recommended Approaches for NPDI research, listed in the order by which a NP would move through the decision trees

Table 1 lists the challenges unique to NPDI research that will be addressed in the respective Recommended Approach.

Recommended ApproachShort DescriptionAddresses NPDI Challenges
1Selection of priority NPs for evaluation as potential precipitants of NPDIs2, 3, and 7–9
2Identification and characterization of optimal NP study materials for NPDIs1, 3, and 8
3Evaluation of a potential NPDI using static and dynamic pharmacokinetic modeling of data obtained from in vitro systems and human pharmacokinetic studies2–6
4Design of phase 0 studies to understand NP constituent pharmacokinetics to inform design of a clinical NPDI study5–7 and 9
5Design of clinical NPDI studies using appropriate NP formulation, object drug(s), and human subject group(s)3–9
6Design and creation of a data repository and public portal of the NaPDI Center’s NPDI data for access by researchers1–3, 8, and 9