DRUG DISCOVERY DEVELOPMENT (DDD): Sponsors meet with FDA → review of the past trials,
design future trials, drug development plan
PROPOSED PROTOCOL→ 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
*AGREEMENT ( FDA and Sponsor) → data required for NDA

LONGEST, MOST COMPREHENSIVE TRIAL regarding efficacy and safety of new compounds

1000-3000 AFFLICTED WITH TARGET ILLNESS→ recruited, tested and monitored

ADR are also monitored; New drug is COMPARED TO COMPETITOR DRUGS or PLACEBO

Question

Sponsors meet with FDA → review of the past trials,
design future trials, drug development plan
PROPOSED PROTOCOL→ 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
*AGREEMENT ( FDA and Sponsor) → data required for NDA

LONGEST, MOST COMPREHENSIVE TRIAL regarding efficacy and safety of new compounds

1000-3000 AFFLICTED WITH TARGET ILLNESS→ recruited, tested and monitored

ADR are also monitored; New drug is COMPARED TO COMPETITOR DRUGS or PLACEBO

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Phase 3 clinical trials

-  95% chance of being approved by FDA
-  Help establish the appropriate format of the
submission

-  Determine if additional animal or human trial is
necessary

DRUG DISCOVERY DEVELOPMENT (DDD)

Phase 3 clinical trials - 95% chance of being approved by FDA - Help establish the appropriate format of the submission - Determine if additional animal or human trial is necessary

Autor