💜 Wir beteiligen Autor*innen bei jedem Buch mit 7 Prozent, so dass viele von ihnen bei jedem verkauften Exemplar doppelt verdienen. → Mehr erfahren

Rift-lines within European regulatory framework for Biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account

Rift-lines within European regulatory framework for Biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account

von Malik Osmane
Taschenbuch - 9783656517399
54,99 €
  • Versandkostenfrei
Auf meine Merkliste
  • Hinweis: Print on Demand. Lieferbar innerhalb von 7 bis 10 Tagen
  • Lieferzeit nach Versand: ca. 1-2 Tage
  • inkl. MwSt. & Versandkosten (innerhalb Deutschlands)
  • Hinweis: Print on Demand. Lieferbar innerhalb von 7 bis 10 Tagen
  • Hinweis: Lieferzeit ca. 1-2 Tage
  • inkl. MwSt. & Versandkosten (innerhalb Deutschlands)

Autorenfreundlich Bücher kaufen?!

Beschreibung

Master's Thesis from the year 2013 in the subject Medicine - Pharmacology, grade: 1 st CLASS HONS, Dublin Institute of Technology (Chemistry), course: Pharmaceutical Quality Assurance / Regulatory Affairs, language: English, abstract: During the course of this thesis evidence was presented and discussed related to the research questions. The fundamental question related to the heterogeneity and variation through the life cycle of the biosimilar and the reference biologic remains neglected, based on the results collected during this thesis, by the stakeholders, mainly because those issues where not addressed in any official regulatory guidance document. As clear guidance from the EMA is lacking, with the only available guidance being that once a marketing authorization is issued it is accepted that the quality profiles of the reference biologic and the biosimilar will have different quality profiles. Abstract: Within the biosimilar development context, there are unaddressed questions by the European Medicines Agency (EMA) with regard to the impacts of shifts of the quality profile (purity- and impurity levels) of the reference biologic for the biosimilar development program. This dynamic is an open issues has potentially implications on the comparability exercise of the before mentioned. Opinions from experts involved in the guidance drafting process of EMA and other were evaluated with regard to the issue.[...]

Details

Verlag GRIN Publishing
Ersterscheinung Oktober 2013
Maße 210 mm x 148 mm x 18 mm
Gewicht 380 Gramm
Format Taschenbuch
ISBN-13 9783656517399
Auflage 1. Auflage
Seiten 260

Schlagwörter