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Item Details
| Title:
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DEVELOPMENT OF SPECIFICATIONS FOR BIOTECHNOLOGY PHARMACEUTICAL PRODUCTS
SYMPOSIUM, SAN FRANCISCO, CALIF., MAY 1996 |
| By: |
F. Brown (Editor), J. Fernandez (Editor) |
| Format: |
Paperback |
| List price:
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£54.60 |
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We currently do not stock this item, please contact the publisher directly for
further information.
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| ISBN 10: |
3805565690 |
| ISBN 13: |
9783805565691 |
| Publisher: |
S KARGER AG |
| Pub. date: |
1 January, 1997 |
| Series: |
Developments in Biologicals v. 91 |
| Pages: |
122 |
| Description: |
A collection of papers discussing the development of specifications for biotechnology pharmaceutical products. Areas examined include in-process and final product specification development, assay and process validation and their effect on specification setting and standards and reference material. |
| Synopsis: |
The papers in this volume are based on the proceedings of a symposium on the development of specifications for biotechnology pharmaceutical products. The papers discuss specifications and the degree to which they are appropriately applied during the various stages of drug development. Papers also evaluate raw material, in-process and final product specification development throughout the drug development timeline for biotechnology pharmaceutical products and consider specifications for identity, purity and activity at various stages of drug development. Further contributions examine assay and process validations and their effects on specification setting, stressing that the quality of the validation directly effects the setting of a suitable specification. Finally, standards and reference material, and their selection for in-house use and as the basis for setting future global standards are discussed. |
| Illustrations: |
21, 21 fig., 16 tab. |
| Publication: |
Switzerland |
| Imprint: |
S Karger AG |
| Returns: |
Non-returnable |
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