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Flawed Bioequivalence Studies Prompt EMA Recommendation to Suspend 136 Drugs


August 01, 2016

The quality of the bioequivalence studies performed by the Semler Research Centre in India is being called into question. The European Medicines Agency has recommended stopping the sale of 136 medications associated with the organization.

The medications included in the recommendation contain the following active ingredients: erlotinib, saquinavir, atovaquone/proguanil, ebastine, tramadol/paracetamol, amoxicillin, among others.

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The manufacturers impacted by this include Mylan, Teva, and Sandoz.

A representative for Novartis told Outsourcing-Pharma.com that it was working with its licensing partners to repeat the bioequivalence/bioavailability studies at an acceptable alternate study site.

 

--Stephanie Vaccaro

 

References:

1. European Medicines Agency. EMA recommends suspension of medicines over flawed studies at Semler Research Center. www.ema.europa.eu. July 22, 2016.

2. Fassbender M. Questions surrounding Indian CRO result in medicine suspension recommendation. www.outsourcing-pharma.com. July 22, 2016.

 

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