Acceptable Intakes for Mutagenic Impurities in Relation to LTL Exposure

Acceptable Intakes for Mutagenic Impurities in Relation to LTL Exposure

Can less than lifetime be applied for nitrosamines?Подробнее

Can less than lifetime be applied for nitrosamines?

Is the Less Than Lifetime (LTL) Limit applies to NITROSAMINES?Подробнее

Is the Less Than Lifetime (LTL) Limit applies to NITROSAMINES?

Calculating limits for carcinogens: AI, PDE, and less than lifetime as per ICH M7Подробнее

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

[Multidisciplinary] ICH M7 AddendumПодробнее

[Multidisciplinary] ICH M7 Addendum

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

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

How to define limit for mutagenic impurity in drug productПодробнее

How to define limit for mutagenic impurity in drug product

ICH M7 - Risk assessment for mutagenic impurities and control strategiesПодробнее

ICH M7 - Risk assessment for mutagenic impurities and control strategies

Nitrosamines risk assessment: step 2Подробнее

Nitrosamines risk assessment: step 2

Risk assessment of potentially mutagenic impurities in drug products approved in BrazilПодробнее

Risk assessment of potentially mutagenic impurities in drug products approved in Brazil

Overview of ICH Guidelines, Less Than Lifetime (LTL) Exposure, and Other Strategies for NitrosaminesПодробнее

Overview of ICH Guidelines, Less Than Lifetime (LTL) Exposure, and Other Strategies for Nitrosamines

Nitrosamine Impurities, NDSRIs and Setting Acceptable Intake (AI) Limits @ToxGyanПодробнее

Nitrosamine Impurities, NDSRIs and Setting Acceptable Intake (AI) Limits @ToxGyan

The purge factor - ICH M7 Option 4Подробнее

The purge factor - ICH M7 Option 4

Purity is a Virtue: A Practical Guide to the Reporting of ImpuritiesПодробнее

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

[Multidisciplinary] M7(R2) / Q&As_ENGПодробнее

[Multidisciplinary] M7(R2) / Q&As_ENG

Why the AI for NDMA is 96ng/day?Подробнее

Why the AI for NDMA is 96ng/day?

NITROSAMINE IMPURITIES I RISK ASSESSMENT I CONTROL STRATEGYПодробнее

NITROSAMINE IMPURITIES I RISK ASSESSMENT I CONTROL STRATEGY

ICH Q&A Review: Dalia Global and MultiCASEПодробнее

ICH Q&A Review: Dalia Global and MultiCASE

Nitrosamine Impurities-Aug 2023 NDSRIs Limit USFDA Guidance | Control of Nitrosamine Guidance Feb-21Подробнее

Nitrosamine Impurities-Aug 2023 NDSRIs Limit USFDA Guidance | Control of Nitrosamine Guidance Feb-21

Applying Expert Knowledge for ICH M7 Classification - Session 2Подробнее

Applying Expert Knowledge for ICH M7 Classification - Session 2

Новости