Regulatory Practice for Biopharmaceutical Production

Inbunden, Engelska, 1994

AvLubiniecki,Vargo,Anthony S. Lubiniecki,Susan A. Vargo

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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

Utgivningsdatum1994-08-30
Mått160 x 235 x 32 mm
Vikt814 g
FormatInbunden
SpråkEngelska
Antal sidor576
FörlagJohn Wiley & Sons Inc
ISBN9780471049005

Tillhör följande kategorier

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

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.