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Extractables & Leachables : [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria /
These proceedings cover all the presentations from this conference which featured a comprehensive representation of best practice examples in pharmaceutical packaging, as well as the latest regulatory and working group updates, analytical chemist perspectives, and technical innovations from top phar...
| Clasificación: | Libro Electrónico |
|---|---|
| Autores Corporativos: | , |
| Formato: | Electrónico Congresos, conferencias eBook |
| Idioma: | Inglés |
| Publicado: |
Vienna, Austria :
Smithers Information Ltd.,
2012.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 9781909030343_FrontCover; Contents; Paper 1 Introduction to extractables and leachables; Paper 2 European regulatory perspective on extractables and leachables; Paper 3 ELSIE Controlled Extraction Studies Pilot Program for plastic materials: achievements, recommendations and future perspectives; Paper 4 PQRI extractable and leachables in parenteral and ophthalmic drug products (PODP): An evolving strategy; Paper 5 The problematic and concrete cases concerning large volume parenteral drugs.
- Paper 6 Understanding the safety qualification process by determining various safety thresholds for leachablesPaper 7 A risk based approach to qualify process aids with respect to E & L's; Paper 8 Procedures for determining acceptable daily exposure (ADE) for leachables into drug products; Paper 9 Toxicological evaluation of E & Ls: in silico and read across, with specific reference to genotoxicity and current guidelines and practice; Paper 10 Extractables and leachables in topical products during development; Paper 11 Extractables & Leachables in the life cycle of dialysis solutions.
- Paper 12 Analysis of drug-packaging interactions via molecular dynamics (MD) simulationsPaper 13 The use of chemometric analysis in the validation of FTIR extractable methods, used as an alternative to chromatographic analysis, as part of a control strategy for plastic extractables; Paper 14 Investigation of inorganic extractables in elastomeric materials for pharmaceutical applications; Paper 15 (Halo)Butyl oligomers in pharmaceutical rubbers; Paper 16 The leachables simulation process; strategies for study design and development and case studies; 9781909030343_BackCover.