Digitale Objekte der Universität Leipzig

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Research Results
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2012-10-22

Safety and Toxicity of Biosimilars in Light of the EU versus the US Regulatory...

The document on hand is conducted to compare the EU versus the US regulatory approaches with regard to a potential impact on the safety profile of a proposed biosimilar product. Biosimilars are of complex nature. In principle, extensive investigations performed within the scope of the development of...

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