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01.07.2023 | News item

Nitrosamine impurity risk assessment required in medicine registration applications

Erschienen in: Reactions Weekly | Ausgabe 1/2023

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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

Titel: Nitrosamine impurity risk assessment required in medicine registration applications
Publikationsdatum: 01.07.2023
Verlag: Springer International Publishing
Erschienen in: Reactions Weekly / Ausgabe 1/2023
Print ISSN: 0114-9954
Elektronische ISSN: 1179-2051
DOI: https://doi.org/10.1007/s40278-023-43457-0

Springer Medizin

Excerpt

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