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01-07-2023 | News item

Nitrosamine impurity risk assessment required in medicine registration applications

Published in: Reactions Weekly | Issue 1/2023

Excerpt

The Australian Therapeutic Administration (TGA) advises that sponsors should consider TGA guidance on nitrosamine impurities in medicines when preparing Category 1 prescription medicine registration applications in Australia. The guidance lists Acceptable Intake (AI) limits for nitrosamine impurities to date, and sponsors should refer to this information to assist them to meet their regulatory obligations. …

Nitrosamine risk assessment in Category 1 prescription medicine registration applications Internet Document : 10 Jul 2023. Available from: URL: https://www.tga.gov.au/news/news/nitrosamine-risk-assessment-category-1-prescription-medicine-registration-applications

Title: Nitrosamine impurity risk assessment required in medicine registration applications
Publication date: 01-07-2023
Publisher: Springer International Publishing
Published in: Reactions Weekly / Issue 1/2023
Print ISSN: 0114-9954
Electronic ISSN: 1179-2051
DOI: https://doi.org/10.1007/s40278-023-43457-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Nitrosamine impurity risk assessment required in medicine registration applications

Excerpt

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

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