Addressing the Complex Problem of Degradation‐Derived Mutagenic Impurities in Drug Substances and Products-Reference-Cited by-同舟云学术

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Addressing the Complex Problem of Degradation‐Derived Mutagenic Impurities in Drug Substances and Products

Published:2021-12-08 Issue: Volume: Page:477-511
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Container-title:Mutagenic Impurities
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Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/9781119551249.ch14

Reference85 articles.

1. International Conference on Harmonisation. (2006).Impurities in New Drug Substances. Q3A(R2). Revised Guideline.

2. International Conference on Harmonisation. (2006).Impurities in New Drug Products. Q3B(R2). Revised Guideline.

3. International Conference on Harmonisation. (2017).Assessment and Control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. M7. Revised guideline (R1).

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