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ICH M7 - Risk assessment for mutagenic impurities and control strategies

ICH M7 - Risk assessment for mutagenic impurities and control strategies

Calculating limits for carcinogens: AI, PDE, and less than lifetime as per ICH M7

Calculating limits for carcinogens: AI, PDE, and less than lifetime as per ICH M7

The purge factor - ICH M7 Option 4

The purge factor - ICH M7 Option 4

ICH M7 Video

ICH M7 Video

ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment

ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment

Mutagenic Impurities from a Drug Substance Perspective: Highlights from ICH M7 Q&A Draft Document

Mutagenic Impurities from a Drug Substance Perspective: Highlights from ICH M7 Q&A Draft Document

Acceptable Intakes for Mutagenic Impurities in Relation to LTL Exposure

Acceptable Intakes for Mutagenic Impurities in Relation to LTL Exposure

ICH M7 - Avaliação do risco de impurezas mutagênicas e estratégias de controle

ICH M7 - Avaliação do risco de impurezas mutagênicas e estratégias de controle

Understanding the Classification of Potentially Mutagenic Impurities as per ICH M7 Guidelines

Understanding the Classification of Potentially Mutagenic Impurities as per ICH M7 Guidelines

07 | ICH M7(R2) Explained: Assessment and control of DNA-reactive (mutagenic) impurities

07 | ICH M7(R2) Explained: Assessment and control of DNA-reactive (mutagenic) impurities

ICH M7, ICH S9, and Nitrosamine Impurities

ICH M7, ICH S9, and Nitrosamine Impurities

Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

ICH M7: Have you got it covered?

ICH M7: Have you got it covered?

How does evidence-based decision making assist Expert Review?

How does evidence-based decision making assist Expert Review?

What is meant by Genotoxicity & Mutagenicity?

What is meant by Genotoxicity & Mutagenicity?

Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

[Multidisciplinary] M7(R2) / Q&As_ENG

[Multidisciplinary] M7(R2) / Q&As_ENG

08 | ICH M7(R2) Explained (Podcast): Assessment and control of DNA-reactive (mutagenic) impurities

08 | ICH M7(R2) Explained (Podcast): Assessment and control of DNA-reactive (mutagenic) impurities

Dynavap M7 Produkt Test

Dynavap M7 Produkt Test

[Multidisciplinary] ICH M7 Addendum

[Multidisciplinary] ICH M7 Addendum

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