Use of In Silico Methods for Regulatory Toxicological Assessment of Pharmaceutical Impurities

Author:

Kovarich Simona,Cappelli Claudia Ileana

Publisher

Springer US

Reference70 articles.

1. ECHA—European Chemical Agency (2008) Guidance on information requirements and chemical safety assessment. Chapter R.6: QSARs and grouping of chemicals. https://echa.europa.eu/documents/10162/13632/information_requirements_r6_en.pdf/77f49f81-b76d-40ab-8513-4f3a533b6ac9. Accessed 31 Mar 2021

2. ICH—International Conference on Harmonisation (2006) Impurities in new drug substances—Q3A(R2). Current Step 4 version. http://www.ich.org/products/guidelines.html. Accessed 31 Mar 2021

3. ICH—International Conference on Harmonisation (2006) Impurities in new drug products—Q3B(R2). Current Step 4 version. http://www.ich.org/products/guidelines.html. Accessed 31 Mar 2021

4. ICH Harmonised Tripartite Guideline (2009) Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals—M3(R2). Current Step 4 version. http://www.ich.org/products/guidelines.html. Accessed 6 May 2015

5. ICH Harmonised Tripartite Guideline (2017) Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk—M7. Current Step 4 version. http://www.ich.org/products/guidelines.html. Accessed 31 Mar 2021

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