Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals
Venue: Sheraton National Hotel Arlington
Location: Arlington, Virginia, United States
Event Date/Time: Feb 03, 2009 | End Date/Time: Feb 04, 2009 |
Description
FEATURED TOPICS
•Characterization of changes in cell lines, process scale, formulation/presentation and the comparative data necessary to support these changes
•Discussion of in vitro biochemical, preclinical (pharmacokinetics, pharmacodynamics, toxicology, immunogenicity), or clinical data needed for some changes and value of these data
•Case studies and the data requested by regulatory authorities.