Regulatory Practice for Biopharmaceutical ProductionISBN: 978-0-471-04900-5
Hardcover
566 pages
July 1994
 This is a Print-on-Demand title. It will be printed specifically to fill your order. Please allow an additional 10-15 days delivery time. The book is not returnable.
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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.
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.
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General Pharmacology & Pharmaceutical Medicine
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