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

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Rift-lines within European regulatory framework for Biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account by Malik Osmane, GRIN Verlag
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Malik Osmane ISBN: 9783656517382
Publisher: GRIN Verlag Publication: October 15, 2013
Imprint: GRIN Verlag Language: English
Author: Malik Osmane
ISBN: 9783656517382
Publisher: GRIN Verlag
Publication: October 15, 2013
Imprint: GRIN Verlag
Language: English

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.[...]

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.[...]

More books from GRIN Verlag

Cover of the book Das Sprechen über Emotionen als Teil der menschlichen Kultur by Malik Osmane
Cover of the book Castigliones 'Libro del Cortegiano' Libro III 'La donna di Palazzo' im Kontext der Erziehungsschriften für das weibliche Geschlecht by Malik Osmane
Cover of the book Anlieferung nach dem Milkrun-Konzept. Planung und Eignung für die Beschaffungslogistik der Automobilindustrie by Malik Osmane
Cover of the book Umweltrecht im Unternehmen by Malik Osmane
Cover of the book Wehrpflicht oder Berufsarmee? by Malik Osmane
Cover of the book Rückwirkung und Dispositionsschutz (§§17, 23 EStG) by Malik Osmane
Cover of the book Gesundheitsmanagement in sozialen Einrichtungen by Malik Osmane
Cover of the book Der Einfluss des Mediums Fernsehen auf das politische Interesse von Jugendlichen im Alter von 12 bis 16 Jahren by Malik Osmane
Cover of the book Technische Dokumentation - Bindeglied zwischen Produkt und Benutzer by Malik Osmane
Cover of the book Die englische Public Limited Company (Limited) und die deutsche GmbH by Malik Osmane
Cover of the book Hat man durch Macht das Recht auf Durchsetzung von Verboten? by Malik Osmane
Cover of the book Kulturtourismus in der Tourismuswerbung - Translatorische Aspekte der Übersetzung von Prospekten am Beispiel der Stadt Pozna? by Malik Osmane
Cover of the book Selbstbestimmtes Lernen und seine Bedeutung für computerunterstützte Lehr- und Lernkonzepte by Malik Osmane
Cover of the book Das Burnout-Syndrom als latente Gefahr für Mitarbeiter und Organisation by Malik Osmane
Cover of the book Grammatische Besonderheiten im gesprochenen Englisch by Malik Osmane
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy