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Problems With Drug Absorption Studies Still ‘Relatively Common’ In EU

Inadequacies Have Drawn Major Objections During Initial EMA Review

 
• By Vibha Sharma

A retrospective analysis of new drugs evaluated by the European Medicines Agency since 2010 shows that a lack of, or major deficiencies in, human mass balance studies is still a concern in regulatory submissions.

Clinical trial
There Is Clear Guidance On Human Mass Balance Studies • Source: Shutterstock

Despite the availability of clear guidance on performing human mass balance studies, which are essential to help understand how drugs are absorbed, metabolized and excreted after dosing, deficiencies on this front are still “relatively common” in new drug applications in the EU.

This could have an impact on the benefit-risk assessment of the proposed medicinal product and lead to unnecessary precautions being added to the product’s labeling, senior regulators warn in a...

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