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pro vyhledávání: '"Mike Cauchy"'
Autor:
Mary Alice Hefford, Mike Cauchy
Publikováno v:
Biologicals. 38:637-643
Demonstrations of bio-similarity between subsequent entry (follow-on) biologics and innovator's formulated drug products may depend upon methods that either remove excipients completely or allow the exchange of excipients to give equivalent formulati
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 30(3)
To be both safe and effective, a therapeutic product must have the correct chemical structure and be free of harmful contaminants. Structure in protein therapeutic products, however, implies not only the correct sequence of amino acids (primary struc