Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation
| Autor: | Lee M. Nagao, Roger O McClellan, Wmark Vogel, David Jacobson-Kram, Timothy McGovern, Ron K. Wolff, Daniel L. Norwood, Douglas J. Ball, James Blanchard |
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| Rok vydání: | 2007 |
| Předmět: |
medicine.medical_specialty
Chronic bronchitis Drug-Related Side Effects and Adverse Reactions media_common.quotation_subject Context (language use) Toxicology Food and drug administration Quality research Environmental health Administration Inhalation medicine Animals Humans Quality (business) Intensive care medicine Physician Quality Reporting System Administration Intranasal media_common United States Food and Drug Administration business.industry Legislation Drug United States Pharmaceutical Preparations Drug product Risk assessment business |
| Zdroj: | Toxicological Sciences. 97:226-236 |
| ISSN: | 1096-0929 1096-6080 |
| Popis: | Safety thresholds for chemical impurities and leachables in consumer products such as foods and drugs have helped to ensure public health while establishing scientifically sound limits for identification and risk assessment of these compounds. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group, a collaboration of chemists and toxicologists from the U.S. Food and Drug Administration (FDA), industry, and academia, has developed safety thresholds for leachables and extractables in orally inhaled and nasal drug products (OINDP), for application in United States pharmaceutical submissions. The PQRI safety concern threshold (SCT) is 0.15 microg/day, and the qualification threshold is 5 microg/day. OINDP are important in the treatment of lung diseases such as asthma and chronic bronchitis, as well as systemic diseases such as diabetes. Analysis of extractables and minimization of leachables in OINDP are vital to ensuring the quality and safety of the final product. It is expected that the thresholds developed by the PQRI Leachables and Extractables Working Group will be used by both industry and regulators to ensure and assess such quality and safety in OINDP applications. In this article, we describe the importance of the PQRI safety thresholds in the OINDP pharmaceutical development process; the background and context of safety thresholds for consumer products; how these safety thresholds were developed using well-established, robust databases and quantitative risk assessment approaches; and how these thresholds can be applied in a pharmaceutical safety qualification process, including FDA regulatory perspectives on the use of safety thresholds for OINDP. |
| Databáze: | OpenAIRE |
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