PL EN

EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

05.06.2014
The guideline addresses the requirements regarding manufacturing processes, the biosimilar comparability exercise for quality, considering the choice of reference medicinal product, analytical methods, physicochemical characterisation, biological activity, purity and quality attributes for relevant specifications of the similar biological medicinal product.

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