Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products
- DOI
- 10.1016/j.yrtph.2026.106245
- Published
- 2026-09
- Container
- Regulatory Toxicology and Pharmacology
- Publisher
- Elsevier BV
- Open access
- unknown
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Cite this work
BibTeX
@article{allodium:10.1016/j.yrtph.2026.106245,
title = {Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products},
author = {Susan P. Felter and Joel P. Bercu and Robert A. Jolly and Timothy J. McGovern and Yi Yang and Alejandra Trejo-Martin and Roland Froetschl and Bodo Haas and Kelly Brant and Alisa Vespa and David J. Ponting and Anthony Lynch and Ashley M. Mudd and Angela White and Andreas Zeller and Raechel Puglisi},
year = {2026},
journal = {Regulatory Toxicology and Pharmacology},
doi = {10.1016/j.yrtph.2026.106245},
url = {https://doi.org/10.1016/j.yrtph.2026.106245}
}RIS
TY - JOUR TI - Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products AU - Susan P. Felter AU - Joel P. Bercu AU - Robert A. Jolly AU - Timothy J. McGovern AU - Yi Yang AU - Alejandra Trejo-Martin AU - Roland Froetschl AU - Bodo Haas AU - Kelly Brant AU - Alisa Vespa AU - David J. Ponting AU - Anthony Lynch AU - Ashley M. Mudd AU - Angela White AU - Andreas Zeller AU - Raechel Puglisi PY - 2026 JO - Regulatory Toxicology and Pharmacology DO - 10.1016/j.yrtph.2026.106245 UR - https://doi.org/10.1016/j.yrtph.2026.106245 ER -
APA
Felter, S. P., Bercu, J. P., Jolly, R. A., McGovern, T. J., Yang, Y., Trejo-Martin, A., Froetschl, R., Haas, B., Brant, K., Vespa, A., Ponting, D. J., Lynch, A., Mudd, A. M., White, A., Zeller, A., & Puglisi, R. (2026). Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2026.106245
Source records
- crossref · retrieved 2026-09-25T12:52:32.562Z