Table of Contents
Causality Assessment in postmarketing adverse events
Evaluation of causality (Question 3)
Evaluation of causality
Individual adverse event causality assessment -Pros
Individual adverse event causality assessment -Pros
Individual adverse event causality assessment -Cons
Criteria to consider for causality assessment
Criteria to consider for causality assessment -2
Criteria to consider for causality assessment -3
Criteria to consider for causality assessment -4
Methods for causality assessment
Methods for causality assessment : WHO index cases
Probability of 3 cases occurring with 300,000 treated patients (Begaud et al, 1995)
Proportional reporting rate
Evaluation of causality- broad categorization
Evaluation of causality- way forward
Evaluation of causality- way forward- 2
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Author: Anshu Vashishtha
Home Page: http://www.fda.gov/cder/meeting/riskManagement.htm
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