Author: Ormsby, Eric ; Rocci, Mario L ; Lindsay, Michael ; Booth, Brian P ; Lowes, Steve ; van Amsterdam, Peter ; Fast, Douglas M ; Savoie, Natasha ; Yin, Xia ; Vallano, Patrick T ; Mawer, Louise ; Garofolo, Fabio ; Phull, Rupinder ; Masse, Robert

The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several ‘hot’ topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.

01 Apr 2009·BioanalysisQ4 · MEDICINE

The 2nd Calibration and Validation Group Workshop on Recent Issues in Good Laboratory Practice Bioanalysis

Q4 · MEDICINE

Article

Author: Vallano, Patrick T ; Garofolo, Fabio ; Hughes, Nicola C ; Rocci Jr, Mario L ; Booth, Brian P ; Hussain, Saleh ; King, S Peter ; Zhu, Zhimeng ; Bradley, Troy ; Savoie, Natasha ; Phull, Rupinder ; Ormsby, Eric ; Lindsay, Michael ; Lowes, Steve ; Viau, Alan

This event was organized by the Calibration and Validation Group (a scientific nonprofit organization based in Toronto, Canada) as a 1.5-day workshop for contract research organizations and pharmaceutical companies involved in providing bioanalytical data for bioavailability, bioequivalence, pharmacokinetic and comparability studies.

01 Jan 2004·Antibodies

Preclinical and clinical safety evaluations

Author: David B. Haughey ; Paula M. Jardieu

The genetic engineering of an immunoglobulin construct with the variable region of a mouse monoclonal antibody (mAb) and the constant region of a human immunoglobulin has resulted in the development and production of chimeric mouse/human mAbs with improved biologic activity, long residence times and reduced immunogenicity (Morrison et al., 1984, Morrison, 1985). In an attempt to further reduce immunogenicity, recombinant DNA technology has been used to generate “humanized” mAbs with mouse sequences largely confined to the hypervariable regions.

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