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- B143eebc18d3d9d55dfaac67bb6ee6979 NCIT_P378 "CDISC" @default.
- B143eebc18d3d9d55dfaac67bb6ee6979 type Axiom @default.
- B143eebc18d3d9d55dfaac67bb6ee6979 annotatedProperty NCIT_P325 @default.
- B143eebc18d3d9d55dfaac67bb6ee6979 annotatedSource NCIT_C49688 @default.
- B143eebc18d3d9d55dfaac67bb6ee6979 annotatedTarget "Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.]" @default.