Integrated Summary Safety (ISS) | PharmaBharat Tools

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Integrated Summary Safety (ISS) | PharmaBharat Tools

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Periodic Benefit-Risk Evaluation Report(PBRER)Development Safety Update Report(DSUR)Aggregate Report ICH E2C(R2) PBRER Periodic Report Schedule Data Lock Point(DLP)Cumulative Safety Data Exposure Estimate Line Listing Summary Tabulation Integrated Summary Safety(ISS)Meta-Analysis Safety Cumulative Case Count Reporting Rate Safety Data Sheet Addendum Report Annual Safety Report(ASR)Benefit-Risk Analysis (Aggregate)Periodic Safety Reporting for Clinical Trials Cumulative Summary Data Lock Point(DLP)Development Safety Update Report(DSUR)EU Reference Date(EURD)Patient Exposure Data International Birth Date(IBD)Interval Data Line Listing Periodic Adverse Drug Experience Report(PADER)Periodic Benefit-Risk Evaluation Report(PBRER)Proposed Product Information Changes Periodic Safety Update Report(PSUR)PSUR Repository Safety Specification Single Assessment Summary Tabulation

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PV Aggregate ReportingIntegrated Summary Safety

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Summary Tabulation Meta-Analysis Safety

Integrated Summary Safety(ISS)

Aggregate Reporting

Definition

Summary of safety across all trials for a drug; part of submission dossier.

Example

ISS for NDA/BLA with cumulative trial safety.

Regulatory source

ICH E2F, E2C

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