TABLE 1.
Workshop symposiums and sessions
| Day 1: September 30, 2021 | Summary citation | |
|---|---|---|
| Symposium I | Mechanistic Modeling of Locally Acting Generic Drug Products | |
| Day 1: Session 1 | Mechanistic Modeling of Orally Inhaled Generic Drug Products | 25 |
| Day 1: Session 2 | Mechanistic Modeling of Dermal Generic Drug Products | 26 |
| Day 1: Session 3 | Mechanistic Modeling of Other Locally Acting Generic Drug Products | 27 |
| Day 2 October 1, 2021 | ||
|---|---|---|
| Symposium II | Mechanistic Modeling of Oral Generic Drug Products | |
| Day 2: Session 1 | Oral PBPK as an Alternative BE Approach and a Tool for Supporting Risk Assessment and Biowaiver | 28 |
| Day 2: Session 2 | Oral PBPK for Evaluating the Impact of Food on BE | 29 |
| Day 2: Session 3 | Challenges and Successful Cases for Oral PBPK | 28 |
|
Symposium III Day 2: Session 4 |
Model Acceptance and Model Sharing for Regulatory Use |
Abbreviations: BE, bioequivalence; PBPK, physiologically based pharmacokinetic.