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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.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 111 | 2 | |a Extractables & Leachables for Pharmaceutical Products |d (2012 : |c Europe) |j issuing body. | |
| 245 | 1 | 0 | |a Extractables & Leachables : |b [E & L 2012 conference proceedings] : delivering pharmaceuticals safely : 12-13 December 2012, Vienna, Austria / |c organised by Smithers Rapra. |
| 246 | 3 | |a Extractables and Leachables : |b [E and L 2012 conference proceedings] | |
| 264 | 1 | |a Vienna, Austria : |b Smithers Information Ltd., |c 2012. | |
| 300 | |a 1 online resource (142 pages) : |b illustrations, portraits | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
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| 500 | |a "Extractables & leachables Europe 2012"--Cover | ||
| 504 | |a Includes bibliographical references. | ||
| 588 | 0 | |a Online resource; title from PDF title page (ebrary, viewed November 8, 2013). | |
| 505 | 0 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 520 | |a 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 pharmaceutical companies and materials suppliers. | ||
| 590 | |a eBooks on EBSCOhost |b EBSCO eBook Subscription Academic Collection - Worldwide | ||
| 650 | 0 | |a Drugs |v Congresses. | |
| 650 | 0 | |a Pharmaceutical industry |v Congresses. | |
| 650 | 6 | |a Médicaments |v Congrès. | |
| 650 | 6 | |a Industrie pharmaceutique |v Congrès. | |
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| 650 | 7 | |a Pharmaceutical industry. |2 fast |0 (OCoLC)fst01060129 | |
| 655 | 7 | |a Conference papers and proceedings. |2 fast |0 (OCoLC)fst01423772 | |
| 710 | 2 | |a Smithers Rapra. | |
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