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Extractables & Leachables for Pharmaceutical Products 2011 : [conference proceedings] : Dublin, Ireland, 27-28 September 2011 /

The examination of extractables and leachables from materials in contact with a drug product or the patient is growing in importance due to increased regulatory scrutiny from organisations such as the Food and Drugs Administration (FDA) and the European Medicines Agency (EMEA). Regulators are concer...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores Corporativos: Extractables & Leachables for Pharmaceutical Products Dublin, Ireland, Smithers
Formato: Electrónico Congresos, conferencias eBook
Idioma:Inglés
Publicado: Dublin : Smithers Rapra Technology Limited, 2011.
Temas:
Acceso en línea:Texto completo
Descripción
Sumario:The examination of extractables and leachables from materials in contact with a drug product or the patient is growing in importance due to increased regulatory scrutiny from organisations such as the Food and Drugs Administration (FDA) and the European Medicines Agency (EMEA). Regulators are concerned with the interaction of various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI) and now parenterals and ophthalmics are of increasing interest, as well as pharmaceutical process equipment. Extractables and leachables assessment of all materials and especially fr.
Notas:"4th international conference, 27-28 September 2011, The Ashling Hotel, Dublin. Maintaining the integrity of drug products through best practice extractables and leachables testing"--Cover
Descripción Física:1 online resource (158 pages) : illustrations, portraits
Bibliografía:Includes bibliographical references.
ISBN:9781847356659
1847356656