Regulatory Practice for Biopharmaceutical Production

Inbunden, Engelska, 1994

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Beskrivning

Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology.

Produktinformation

Utgivningsdatum:1994-08-30
Mått:160 x 235 x 32 mm
Vikt:814 g
Format:Inbunden
Språk:Engelska
Antal sidor:576
Förlag:John Wiley & Sons Inc
ISBN:9780471049005

Utforska kategorier

Farmakologi inom Medicin
Biokemisk teknik inom Naturvetenskap och teknik
Tillverkningsteknik inom Naturvetenskap och teknik

Mer om författaren

Anthony S. Lubiniecki and Susan A. Vargo are the authors of Regulatory Practice for Biopharmaceutical Production, published by Wiley.

Innehållsförteckning

Partial table of contents: A U.S. View of New Biotechnology Regulation (H. Miller). Genetic Stability of Host Cell and Product (M. Wiebe & N.Lin). Quality Control Issues for the New Biotechnology (S. Vargo). Strategic Decisions in Process Design (A. Lubiniecki). Experience in Manufacturing, Testing, and Licensing a Hepatitis BVaccine Produced by Recombinant Technology (A. Elliott, etal.). Tissue Plasminogen Activator: Regulatory Issues (D. Beebe & G.Murano). Recombinant Peptide Hormones (Y.-y. Chiu). Cytokine and Growth Factor Products (L. Dujack & K.Zoon). Licensing Biotechnology Facilities (R. Devine). Computerized Systems Validation (R. Branning). Regulation of Pharmaceuticals in Japan (M. Dibner). Unresolved Issues (T. Copmann & J. Petricciani). Index.