Table 5 Studies agreed upon in the PIPs of ODs
Measure | N |
|---|---|
Quality | |
- Development of age appropriate formulation | 14 |
- Assessment of acceptability/ palatability | 2 |
- Bioequivalence | 1 |
- Microbiological testing | 2 |
Total | 19 |
Non-clinical | |
- Juvenile toxicity study | 20 |
- Other | 8 |
Total | 28 |
Clinical | |
- Meta-analysis | 1 |
- Randomised, double blind, placebo controlled | 25 |
- Comparative, open label | 20 |
- Uncontrolled | 41 |
- Observational | 3 |
- Bioequivalence/ bioavailability | 5 |
- (PB)PK | 2 |
- Pooled data | 3 |
- Extrapolation | 3 |
- Other | 1 |
Total | 104 |