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Search results with tag "Similar biological medicinal"
Guideline on similar biological medicinal products ...
www.ema.europa.euThe Guideline on similar biological medicinal products containing biotechnology -derived proteins as active substance: quality issues lays down the quality requirements for a biological medicinal product claiming to be similar to another one already marketed.
Guideline on similar biological medicinal products ...
www.ema.europa.euGuideline on similar biological medicinal products containing biotechnology -derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/05 Rev.1) lays down the non-clinical and clinical requirements for a …
Guideline on similar biological medicinal products ...
www.ema.europa.euGuideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues