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- W4290804301 abstract "Phase 3 is considered as the confirmation phase in a drug development journey, where the candidate drug's efficacy is confirmed, the drug safety is further demonstrated, and the benefit-risk profile is defined. This chapter summarizes the key considerations for Phase 3 planning, which include the dose proposal for Phase 3, design considerations for safety and efficacy confirmation, statistical analysis plan, pre-specification, patient population, efficacy and safety endpoint planning, various factors impacting Phase 3 success. Developmental prioritization and innovations in attempt to enhance Phase 3 success and drug's benefit-risk profile for patients are also be discussed. If the efficacy evidence collected in a Phase 3 trial is the primary support for approval, the Phase 3 trial's protocol can be submitted for Special Protocol Assessment with Food and Drug Administration's agreement for review. Target value profile evolves from target product profile and emphasizes on values to patients and unmet medical needs." @default.
- W4290804301 created "2022-08-12" @default.
- W4290804301 creator A5036246350 @default.
- W4290804301 date "2022-08-11" @default.
- W4290804301 modified "2023-10-12" @default.
- W4290804301 title "Phase 3" @default.
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- W4290804301 doi "https://doi.org/10.1002/9781119913276.ch9" @default.
- W4290804301 hasPublicationYear "2022" @default.
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