An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment
| Autor: | Wilfried J.T.M. Keurentjes, Agnieszka Ceszlak, Lance Smallshaw, Elaine Shannon, David Wilkinson, Carol A. Marchant, Nancy Lewen, Radu Horga, Frans A. Maris, John Glennon, Sarah Thompson, Laurence James Harris, Mark Schweitzer, Laura Rutter, Joan Gil Bejar, Ruth Boetzel, Helmut Rockstroh, Christopher Day, Peter L. Jacobs, Andrew Teasdale, Crina I. Heghes, Samuel Powell, Carlos Lee, Fiona King, William Nye, Patrick Drumm |
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| Rok vydání: | 2018 |
| Předmět: |
Databases
Factual Database Chemistry Pharmaceutical Pharmaceutical Science Excipient 02 engineering and technology 021001 nanoscience & nanotechnology computer.software_genre 030226 pharmacology & pharmacy Excipients 03 medical and health sciences 0302 clinical medicine Pharmaceutical Preparations medicine Humans Environmental science Drug product Regulatory science Elemental impurities Drug Contamination 0210 nano-technology Risk assessment computer medicine.drug |
| Zdroj: | Journal of Pharmaceutical Sciences. 107:2335-2340 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2018.04.009 |
| Popis: | To support the practical implementation of the International Council for Harmonisation (ICH) Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceutical companies has established a database to collate the results of analytical studies of the levels of elemental impurities within pharmaceutical excipients. This database currently includes the results of 26,723 elemental determinations for 201 excipients and represents the largest known, and still rapidly expanding, collection of data of this type. Analysis of the database indicates good coverage of excipients relevant to real-world drug product formulations and tested element profiles consistent with ICH Q3D recommendations. The database includes the results from multiple analytical studies for an excipient and thus incorporates within it an indication of both excipient supplier and batch-to-batch variability as well as any variability associated with the different testing organizations and methods employed. The data confirm the findings of earlier smaller studies that elemental impurity concentrations in excipients are generally low and when used in typical proportions in formulated drug products are unlikely to pose a significant patient safety risk. The database is now in active use as one line of evidence in ICH Q3D risk assessments. |
| Databáze: | OpenAIRE |
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