التفاصيل البيبلوغرافية
| العنوان: |
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses |
| المؤلفون: |
Hans-Peter Spirkl, Michelle O. Kenyon, Alessandro Brigo, Dave Bower, Dennie S. Welch, Eric Dowdy, Naomi L. Kruhlak, Penny Leavitt, Angela White, Glenn J. Myatt, Sandy Weiner, Wolfgang Muster, Alexander Amberg, James Harvey, Kevin P. Cross, Jacky Van Gompel, Raymond Kemper, Joerg Wichard, Masamitsu Honma, Joel P. Bercu, M. Vijayaraj Reddy, Andrew Teasdale, Catrin Hasselgren, Lisa Beilke, Scott Miller, John Nicolette, Susanne Glowienke, Lidiya Stavitskaya, Robert A. Jolly, Kevin A. Ford, Krista L. Dobo, Mark Powley, Andreja Plaper, Laura Custer, Donald P. Quigley |
| المصدر: |
Regulatory Toxicology and Pharmacology. :13-24 |
| بيانات النشر: |
The Authors. Published by Elsevier Inc. |
| مصطلحات موضوعية: |
0301 basic medicine, Hazard (logic), Models, Molecular, Databases, Factual, Computer science, Carcinogenicity Tests, Quantitative Structure-Activity Relationship, Guidelines as Topic, 010501 environmental sciences, computer.software_genre, Toxicology, 01 natural sciences, Risk Assessment, Mutagenic impurities, (Q)SAR, 03 medical and health sciences, Animals, Data Mining, Humans, Toxicity databases, Carcinogenicity Test, Computer Simulation, Policy Making, 0105 earth and related environmental sciences, Molecular Structure, Guideline adherence, Mutagenicity Tests, Experimental data, General Medicine, Guideline, Regulatory Submission, Ames test, Expert review, 030104 developmental biology, Mutagenesis, Data mining, Guideline Adherence, Risk assessment, Mutagenicity Test, computer, DNA Damage, Mutagens, ICH M7, Impurities |
| الوصف: |
The ICH M7 guideline describes a consistent approach to identify, categorize, and control DNA reactive, mutagenic, impurities in pharmaceutical products to limit the potential carcinogenic risk related to such impurities. This paper outlines a series of principles and procedures to consider when generating (Q)SAR assessments aligned with the ICH M7 guideline to be included in a regulatory submission. In the absence of adequate experimental data, the results from two complementary (Q)SAR methodologies may be combined to support an initial hazard classification. This may be followed by an assessment of additional information that serves as the basis for an expert review to support or refute the predictions. This paper elucidates scenarios where additional expert knowledge may be beneficial, what such an expert review may contain, and how the results and accompanying considerations may be documented. Furthermore, the use of these principles and procedures to yield a consistent and robust (Q)SAR-based argument to support impurity qualification for regulatory purposes is described in this manuscript. |
| اللغة: |
English |
| تدمد: |
0273-2300 |
| DOI: |
10.1016/j.yrtph.2016.02.004 |
| URL الوصول: |
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb24f74a2f8922885931c89451a7cc63 |
| Rights: |
OPEN |
| رقم الانضمام: |
edsair.doi.dedup.....fb24f74a2f8922885931c89451a7cc63 |
| قاعدة البيانات: |
OpenAIRE |