Licensing of a drug for a specific medical condition
Only after careful and extensive review of all available safety and efficacy data derived from preclinical and clinical trials will a regulatory body approve the licensing of a drug for a specific...
View ArticleLicensing of a drug for a specific medical condition: Side effects / buy...
MMF was extensively studied in the early 1990s as an immunosuppressive agent for use in patients undergoing organ transplantation. As a result, licensing trials were confined to transplant recipients...
View ArticleLicensing of a drug for a specific medical condition: Theoretical justification
Autoimmune chronic hepatitis is an immunologically mediated disease and MMF is a potent immunosuppressive agent. Thus, on the surface it seems reasonable to assume that MMF would be of value in...
View ArticleLicensing of a drug for a specific medical condition: Patient-specific features
In the patient population described by the Calgary investigators (mild to moderate serum aminotransferase abnormalities), the associated five- and 10-year life expectancies exceed 80% . Thus, not all...
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