Search Results - "Krummen, Kurt"
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Statistical Evaluation of Stability Data of Pharmaceutical Products for Specification Setting
Published in Drug development and industrial pharmacy (1997)“…Abstract Recent experience has shown that the regulatory authorities try to narrow specifications for a new drug product closely around stability data that…”
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Journal Article -
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Quality assurance after process changes of the production of a therapeutic antibody
Published in Pharmaceutica acta Helvetiae (01-12-1996)“…Process development for the production of a therapeutic humanised antibody is a very complex operation. It involves recombinant genetics, verification of a…”
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Journal Article