Foreign particles testing in orally inhaled and nasal drug products
| Autor: | Lee M. Nagao, Richard Malcolmson, Barbara Haeberlin, Steen Jensen, Glenn Thompson, Claire D Abreu Hayling, Stanley Mittelman, Mikael Sundahl, John L. Hart, Caesar Snodgrass-Pilla, Raouf Ghaderi, James Blanchard, Ronald Wolff, Sonja Sekulic, James Coleman |
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| Rok vydání: | 2005 |
| Předmět: |
Drug
Drug Contamination media_common.quotation_subject Best practice Pharmacology toxicology Drug Evaluation Preclinical Pharmaceutical Science Nanotechnology Pharmacy Food and drug administration Public discussion Administration Inhalation Medicine Animals Humans Pharmacology (medical) Quality (business) Metered Dose Inhalers Administration Intranasal media_common Pharmacology business.industry Organic Chemistry Public relations Pharmaceutical Preparations Molecular Medicine business Biotechnology |
| Zdroj: | Pharmaceutical research. 21(12) |
| ISSN: | 0724-8741 |
| Popis: | The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) presents this paper in order to contribute to public discussion regarding best approaches to foreign particles testing in orally inhaled and nasal drug products (OINDPs) and to help facilitate development of consensus views on this subject. We performed a comprehensive review of industry experience and best practices regarding foreign particles testing in OINDPs, reviewed current guidances and techniques, and considered health and safety perspectives. We also conducted and assessed results of an industry survey on U.S. Food and Drug Administration requirements for foreign particles testing. We provide here a result of our review and survey: a summary of industry best practices for testing and controlling foreign particles in OINDPs and proposals for developmental characterization and quality control strategies for foreign particles. We believe that clear consensus-based recommendations and standards for foreign particles testing and control in OINDPs are needed. The proposals contained in this paper could provide a starting point for developing such consensus recommendations and standards. |
| Databáze: | OpenAIRE |
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