Regulatory aspects of evaluating combination treatments in autoimmune diseases
Thus far, attempts to control major autoimmune diseases by solo therapy have not been very successful in the prevention of end organ damage. Toxicity of long-term solo therapy is a dose-limiting factor with many agents, such as cytotoxic agents, other immunosuppressive agents and corticosteroids . Combination therapies with existing therapeutic agents may be necessary for better control of autoimmune diseases.
KeywordsRheumatoid Arthritis Autoimmune Disease Medicinal Product Marketing Authorisation Regulatory Aspect
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