Semler Research

EMA suspends Semler’s medicines over flawed studies

Monday, July 25, 2016

The EMA has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. The Agency has also recommended that medicines currently being evaluated for authorization and which rely only on bioequivalence studies from this site should not be authorized until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.

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Clinical research in India: Despite setbacks, opportunity continues

Monday, May 2, 2016

India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blemishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future.

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