Table 2. Less frequent combinations in integrated protocols (based on 164 protocols).
| Number of trial elements within integrated protocols | Combined trial elements | Number |
|---|---|---|
| 12 protocols with 4 trial elements |
SD+MD+age+gender | 3 |
| SD+MD+food+DDI | 2 | |
| MD+food+gender+abs/rel BA | 1 | |
| SD+food+age+gender | 1 | |
| SD+food+gender+abs/rel BA | 1 | |
| SD+MD+food+abs/rel BA | 1 | |
| SD+MD+food+age | 1 | |
| SD+MD+food+ethn br | 1 | |
| SD+MD+food+gender | 1 | |
| 7 protocols with 5 trial elements |
SD+food+age+gender+abs/rel BA | 1 |
| SD+MD+DDI+age+gender | 1 | |
| SD+MD+food+age+abs/rel BA | 1 | |
| SD+MD+food+age+gender | 1 | |
| SD+MD+food+DDI+age | 1 | |
| SD+MD+food+DDI+gender | 1 | |
| SD+MD+food+gender+abs/rel BA | 1 | |
| A total of 2 protocols with ≥ 6 trial elements |
SD+MD+food+age+gender+ethn br | 1 |
| SD+MD+food+DDI+age+gender+ethn br | 1 |
SD = single ascending dose; MD = multiple ascending dose; food = drug-food interaction; DDI = drug-drug interaction; abs/rel BA = absolute/relative bioavailability; ethn br = ethnic bridging.