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