Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals
|Event Date/Time: Feb 03, 2009||End Date/Time: Feb 04, 2009|
â€¢Characterization of changes in cell lines, process scale, formulation/presentation and the comparative data necessary to support these changes
â€¢Discussion of in vitro biochemical, preclinical (pharmacokinetics, pharmacodynamics, toxicology, immunogenicity), or clinical data needed for some changes and value of these data
â€¢Case studies and the data requested by regulatory authorities.