Table 3.
Examples of Extrapolation Approaches With No Change Over Time.
| Disease/Indications | Extrapolation
|
Present Approach | |
|---|---|---|---|
| Current Data (n) | Dunne’s Reference (n) | ||
| Oncology products | No (n = 7) | No (n = 10) | Remains the same |
| ADHD (6–12 y) | No (n = 6) | No (n = 2) | Remains the same |
| ADHD (13–17 y) | Partial (n = 1) | Partial (n = 2) | Remains the same |
| MDD | No (n = 1) | No (n = 1) | Remains the same |
| HSV and VZV infections | Complete (n = 3) | Complete (n = 1) | Remains the same |
| HBV infection | Partial (n = 2) | Partial (n = 1) | Remains the same |
| HIV infection | Partial (n = 3) | Partial (n = 1) | Remains the same |
| HCV infection | Partial (n = 1) | Partial (n = 1) | Remains the same |
Abbreviations: ADHD, attention-deficit hyperactivity disorder; MDD, Major Depression Disorder; HSV, herpes simplex virus; VZV, varicella zoster virus; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus.