P. R. McAllister

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The ability to prepare consistent biopharmaceutical products depends extensively on possession of banked and characterized cell substrates and on development of production processes which can be validated. While the attributes that define cell characterization have been extensively detailed by ICH and the regulatory agencies in the past decade, little has(More)
For products derived from continuous cell lines, regulatory agencies worldwide require that the purification process be validated for its ability to remove or inactivate potential contaminants such as viruses and virus-like particles. New guidance suggests a requirement for statistical evaluation of these studies but the industry has yet to develop such(More)
An econometric-type model was developed that describes the relationship between federal biomedical funding and the number, subject area and research level (clinical to basic) of published papers in biomedical journals. The study covered federal biomedical funding over the period 1962–1979 and biomedical literature counts over the period 1965–1979. A unique(More)
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