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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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.[.]. …

Taschenbuch. Zustand: Neu. Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account | Malik Osmane | Taschenbuch | 284 S. | Englisch | 2015 | Anchor Academic Publishing | EAN 9783954891870 | Verantwortliche Person für die EU: Bedey & Thoms Media GmbH, Björn Bedey, Hermannstal 119k, 22119 Hamburg, info[at]diplom[dot]de | Anbieter: preigu.…

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Taschenbuch. Zustand: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer's point of view is to incorporate a design space. 284 pp. Englisch.…

Taschenbuch. Zustand: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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.[.] 260 pp. Englisch.…

Taschenbuch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer's point of view is to incorporate a design space.…

Kartoniert / Broschiert. Zustand: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a similar biologic a.…

Zustand: New. Print on Demand pp. 284 24:B&W 5.83 x 8.27 in or 210 x 148 mm (A5) Perfect Bound on Creme w/Gloss Lam.

Zustand: New. Print on Demand pp. 284.

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Taschenbuch. Zustand: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer¿s point of view is to incorporate a design space.Books on Demand GmbH, Überseering 33, 22297 Hamburg 284 pp. Englisch.…

Taschenbuch. Zustand: Neu. Rift-lines within European regulatory framework for Biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account | Malik Osmane | Taschenbuch | 260 S. | Englisch | 2013 | GRIN Verlag | EAN 9783656517399 | Verantwortliche Person für die EU: GRIN Publishing GmbH, Waltherstr. 23, 80337 München, info[at]grin[dot]com | Anbieter: preigu Print on Demand.…

Zustand: New. Print on Demand pp. 260.

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Zustand: New. PRINT ON DEMAND pp. 260.