… and risk minimization activities is heavily dependent on whether the safety specifications
have … In order to allow the monitoring period to all target drugs, we analyzed drugs containing …

… and sponsors agree should be conducted post-approval with … or labeling suggest monitoring
and dose adjustment as … P-gp, 2 PMRs specified rosuvastatin as a probe substrate for …

… also affected the sodium and calcium channel activities of … by the Food and Drug
Administration in 2003, is used to treat … , rosuvastatin should be used with active monitoring for QT …

… in the pre- or post-approval setting, and revisions might be triggered by scientists at the FDA,
the … /cleared tests, merits of testing beyond INR monitoring, and actual feasibility of genetic …

… Fibrates are a class of lipid modifying drugs which are … the extent to which they are used
post-approval will be their cost … by the independent data monitoring committee due to insufficient …

… that show activity on specific disease parameters and are safe may … symptoms and to
improve monitoring and communication of … restrictiveness is also manifest in required post-approval …

… Food and drug administration approved its use for adults patients with primary … Like other
drugs of this class, the benefits of rosuvastatin are independent of LDL-C baseline levels but …

… that show activity on specific disease parameters and are safe may … symptoms and to
improve monitoring and communication of … restrictiveness is also manifest in required post-approval …

… role in the post-approval surveillance of prescription drugs and … or class action litigation—involving
rosuvastatin during the … this study was exempt from Institutional Review Board review. …

… which how the FDA evaluates drug safety information, how it … term postmarketing surveillance
to indicate PV activities, in … drug utilization review, is more like a research activity, although …