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E & L USA : Extractables & Leachables : [conference proceedings] : delivering pharmaceuticals safely : 7-9 May 2013, Providence, RI, USA /
These proceedings cover all the presentations from this second E & L USA conference. Organized by Smithers Rapra the conference once again brought together the pharmaceutical supply chain and discussed the latest research in minimizing the risks associated with extractables and leachables. The c...
| Clasificación: | Libro Electrónico |
|---|---|
| Autores Corporativos: | , |
| Formato: | Electrónico Congresos, conferencias eBook |
| Idioma: | Inglés |
| Publicado: |
Providence, RI :
Smithers Information Ltd.,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 9781909030664_Front Cover; Contents; THE REGULATORY STANDPOINT; Paper 1 Introduction to extractables and leachables; Paper 2 Regulatory perspective; UPDATES FROM INDUSTRY WORKING GROUPS; Paper 3 PQRI-PODP working group update; Paper 4 The United States Pharmacopeia and the issue of leachables and extractables: past, present and future; Paper 5 Risk management concepts and strategies applied to materials quality; E & L APPLICATIONS & CONSIDERATIONS; Paper 6 Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems Including case studies.
- Paper 7 Product equivalency for medical devices case studies for biodegradable and permanent implantable devices; Paper 8 Extractable and leachable studies of twist-off ports (T.O.P.) used for blood pack containers; E & L CASE STUDIES ON PARENTERALS; Paper 9 E & L's from elastomeric components for parenteral packaging: Understanding the impact of process parameters and sterilization methods; Paper 10 Extractable and leachable study of container closure/delivery systems for parenteral medications; TOXICOLOGICAL PERSPECTIVES ON E & LS.
- Paper 11 Determining acceptable levels of leachables into pharmaceutical products
- a toxicological perspectivePaper 12 Case studies of toxicology risk assessment of extractables and leachables; Paper 13 Current status of the ELSIE; demonstration of the practical use of the ELSIE safety database for the rapid assessment of risk from a controlled extraction study; MATERIALS COMPOSITION AND QUALITY; Paper 14 Correlating material composition to extractables and then to leachables.
- Paper 15 Characterization of E & L associated with pharmaceutically relevant materials: some analytical challenges and case studiesCHALLENGES IN E & L STUDIES; Paper 16 (Halo)butyl rubber oligomers in pharmaceutical rubbers; Paper 17 Case studies relating to implantable medical device and biologic products; Paper 18 Analytical challenges associated with high toxicological risk compounds (Nitrosamines): Raising the Safety Concern Threshold; 9781909030664_BackCover.