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European drug regulator suspends medicines tested at Semler Research

European Medicines Agency has cited flaws in bioequivalence studies, which are required for the approval of generics, conducted at the Bangalore-based CRO as the reasons for suspension

BS B2B Bureau  |  Mumbai 

The European Medicines Agency (EMA) has recommended suspension of many approved medicines for which bioequivalence studies were conducted at Bangalore-based contract research organisation (CRO) Semler Research Centre Pvt Ltd. The agency has also recommended that medicines currently being evaluated for authorisation and which rely only on bioequivalence studies from Semler site should not be authorised until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines. “A number of medicines for use in ...

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European drug regulator suspends medicines tested at Semler Research

European Medicines Agency has cited flaws in bioequivalence studies, which are required for the approval of generics, conducted at the Bangalore-based CRO as the reasons for suspension

European Medicines Agency has cited flaws in bioequivalence studies, which are required for the approval of generics, conducted at the Bangalore-based CRO as the reasons for suspension The European Medicines Agency (EMA) has recommended suspension of many approved medicines for which bioequivalence studies were conducted at Bangalore-based contract research organisation (CRO) Semler Research Centre Pvt Ltd. The agency has also recommended that medicines currently being evaluated for authorisation and which rely only on bioequivalence studies from Semler site should not be authorised until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines. “A number of medicines for use in ... image
Business Standard
177 22

European drug regulator suspends medicines tested at Semler Research

European Medicines Agency has cited flaws in bioequivalence studies, which are required for the approval of generics, conducted at the Bangalore-based CRO as the reasons for suspension

The European Medicines Agency (EMA) has recommended suspension of many approved medicines for which bioequivalence studies were conducted at Bangalore-based contract research organisation (CRO) Semler Research Centre Pvt Ltd. The agency has also recommended that medicines currently being evaluated for authorisation and which rely only on bioequivalence studies from Semler site should not be authorised until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines. “A number of medicines for use in ...

image
Business Standard
177 22