Guideline on clinical investigation of medicinal products in the treatment of lipid disorders
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چکیده
This guideline replaces the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CPMP/EWP/3020/03)’. Rev. 1 and Rev. 2 were combined: Rev. 1 was regarding imaging surrogate endpoints Rev. 2 was regarding the need for outcome studies based on safety data at the time of Marketing Authorisation Application.
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