Biosimilars : Design and Analysis of Follow-on Biologics.

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific ch...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Chow, Shein-Chung
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken : CRC Press, 2013.
Colección:Chapman & Hall/CRC biostatistics series.
Temas:
Biological products.
Drugs > Generic substitution.
Pharmaceutical biotechnology industry.
Pharmaceutical biotechnology.
Pharmaceutical policy.
Biologicals.
Biological Factors
Biological Products
Produits biologiques.
Médicaments > Dénomination commune.
Biotechnologie pharmaceutique > Industrie.
Biotechnologie pharmaceutique.
Médicaments > Politique gouvernementale.
Médicaments biologiques.
Biologicals
Biological products
Drugs > Generic substitution
Pharmaceutical biotechnology
Pharmaceutical biotechnology industry
Pharmaceutical policy
Acceso en línea:Texto completo
Descripción
Sumario:As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products. Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity.
Descripción Física:1 online resource (433 pages).
ISBN:9781466579705
1466579706

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