DRUG DISCOVERY DEVELOPMENT (DDD): Phase 3 clinical trials

1 inclusion/exclusion criteria, dosing regimens, methods and timing of data collection, duration of tx and follow-up assessments, etc.→ LIMIT THE BIAS of TRIAL RESULTS

2 data required for NDA

3 Prior to start of Phase 3- __ should be optimized

Question

Phase 3 clinical trials

1 inclusion/exclusion criteria, dosing regimens, methods and timing of data collection, duration of tx and follow-up assessments, etc.→ LIMIT THE BIAS of TRIAL RESULTS

2 data required for NDA

3 Prior to start of Phase 3- __ should be optimized

LEIGHTON DWIGHT OBILLOS · Accepted Answer

.

1 PROPOSED PROTOCOL

2 AGREEMENT ( FDA and Sponsor)

3 final market formulation

DRUG DISCOVERY DEVELOPMENT (DDD)

Phase 3 clinical trials 1 inclusion/exclusion criteria, dosing regimens, methods and timing of data collection, duration of tx and follow-up assessments, etc.→ LIMIT THE BIAS of TRIAL RESULTS 2 data required for NDA 3 Prior to start of Phase 3- __ should be optimized

. 1 PROPOSED PROTOCOL 2 AGREEMENT ( FDA and Sponsor) 3 final market formulation

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