Table 1. Frequent combinations in integrated protocols (based on 164 protocols).
Number of trial elements within integrated protocols | Combined trial elements | Number |
---|---|---|
87 protocols with 2 trial elements |
SD+MD | 34 |
SD+food | 20 | |
SD+abs/rel BA | 6 | |
Food+abs/rel BA | 5 | |
MD+food | 5 | |
Gender+abs/rel BA | 3 | |
Abs/rel BA+mass bal | 2 | |
MD+DDI | 2 | |
Variousa | 10 | |
56 protocols with 3 trial elements |
SD+MD+food | 20 |
SD+MD+abs/rel BA | 5 | |
SD+MD+DDI | 5 | |
SD+MD+gender | 3 | |
SD+food+abs/rel BA | 3 | |
SD+food+gender | 3 | |
SD+MD+ethn br | 2 | |
MD+age+gender | 2 | |
MD+DDI+age | 2 | |
SD+MD+age | 2 | |
SD+MD+ethn br | 2 | |
Variousb | 7 |
SD = single ascending dose; MD = multiple ascending dose; food = drug-food interaction; DDI = drug-drug interaction; abs/rel BA = absolute/relative bioavailability; mass bal = mass balance; ethn br = ethnic bridging. aage+abs/rel BA (1), age+gender (1), food+age (1), food+DDI (1), food+gender (1), MD+abs/rel BA (1), MD+age (1), SD+DDI (1), SD+ethn br (1), SD+gender (1). bAge+gender+ethn br (1), food+age+gender (1), MD+ethn br+abs/rel BA (1), MD+food+DDI (1), SD+age+gender (1), SD+food+ethn br (1), SD+food+PET occupancy (1).