Guideline on clinical investigation of medicinal products in the treatment of lipid disorders

ثبت نشده
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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD)

Keywords Chronic obstructive pulmonary disease (COPD), airflow obstruction, relief of symptoms, maintenance treatment, exacerbations. 1 correction related to a change on p. 4 Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) EMA/CHMP/700491/2012 2/17 Guideline on clinical investigation of medicinal products in the treatmen...

متن کامل

Draft Guideline on clinical investigation of medicinal products for the treatment of acute heart failure (CHMP/EWP/2986/03 Rev 1)

7 This guideline replaces addendum CPMP/EWP/2986/03 " Note for guidance on clinical investigation of 8 medicinal products for the treatment of cardiac failure – addendum on acute cardiac failure ". 9 10 Comments should be provided using this template. The completed comments form should be sent to [email protected] 11 Keywords Acute heart failure, acute decompensated heart failure, ...

متن کامل

Clinical and experimental effects of Nigella sativa and its constituents on respiratory and allergic disorders

Objective: Black cumin or Nigella sativa (N. sativa) seed has been widely used traditionally as a medicinal natural product because of its therapeutic effects. In this review, the medicinal properties of N. sativa as a healing remedy for the treatment of respiratory and allergic diseases, were evaluated. Material and Methods: Ke...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره   شماره 

صفحات  -

تاریخ انتشار 2014