Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues' Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
متن کاملConcept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
متن کاملGuideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)
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Biosimilar, biobetter and next generation therapeutic antibodies
On November 18, 2010, the European Medicine Agency (EMA) released a draft guideline on similar medicinal products containing monoclonal antibodies (mAbs), following a workshop organized by the agency in London on July 2, 2009. The guideline discusses relevant animal model, non-clinical and clinical studies that are recommended to establish the similarity and the safety of a biosimilar compared ...
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