FDA “Case Studies” On Dosing Problems Include Lotronex, Crestor
Executive Summary
FDA believes that use of an exposure-response analysis to establish the optimal dose of GlaxoSmithKline's irritable bowel syndrome agent Lotronex would have prevented its withdrawal
You may also be interested in...
Clinical Trials Should Include Finding Maintenance Dose, FDA’s Temple Says
Maintenance doses are not sufficiently studied in clinical trials, FDA Center for Drug Evaluation & Research Medical Policy Director Robert Temple, MD, said
Clinical Trials Should Include Finding Maintenance Dose, FDA’s Temple Says
Maintenance doses are not sufficiently studied in clinical trials, FDA Center for Drug Evaluation & Research Medical Policy Director Robert Temple, MD, said
Merck Sees Strong Cholesterol Market In ‘04; Zocor Growth, Profit From Zetia
Merck expects Zocor sales to remain in the $5 bil. range in 2004 despite generic erosion overseas and the introduction of new competitors in the cholesterol class