Module 3 2019

How are acceptance criteria set?

Considering Staged Risk

Threshold

Exploratory Dev

Full Dev

Reporting

0.05%

ICH

Identification

0.10%

ICH

Phases 1 and 2

Phase 3

Qualification

DS 0.5%

DP 0.5%

ICH

Identified*

Unidentified

0.2% 0.2%

* Provided no structural alert (e.g. for GenTox)

Impurities acceptance criteria >0.5% only if agreed qualified by Safety Sciences

In early Phases: if study duration is sufficiently long, default to Full Development controls

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