Table 5 Extrapolation from non-Japanese pediatric studies and studies in both Japanese adults and/or older children
From: Clinical data required for the approval of pediatric pharmaceuticals in Japan
Japanese study only | Japanese and non-Japanese studies | Multinational study | Non-Japanese study only | No pediatric study | Total number of studies | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
All productsa | 31 | 18.1% | 36 | 21.1% | 46 | 26.9% | 25 | 14.6% | 33 | 19.3% | 171 |
1. A confirmatory study was completed only in Japanese participants | 10 | 100.0% | 10 | ||||||||
2. Extrapolation from non-Japanese children | 3 | 3.2% | 23 | 24.7% | 41 | 44.1% | 17 | 18.3% | 9 | 9.7% | 93 |
3. Extrapolation from Japanese adults and/or older children | 14 | 14.0% | 21 | 21.0% | 33 | 33.0% | 18 | 18.0% | 14 | 14.0% | 100 |
4. PMDA review without any of the above | 6 | 21.4% | 3 | 10.7% | 1 | 3.6% | 2 | 7.1% | 16 | 57.1% | 28 |