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Recognition and identification of UV-absorbing leachables in EPREX pre-filled syringes: an unexpected occurrence at a formulation-component interface

Autor: James, Pang, Tim, Blanc, John, Brown, Steven, Labrenz, Annabelle, Villalobos, Anneli, Depaolis, Srinivas, Gunturi, Steve, Grossman, Peter, Lisi, George A, Heavner

Publikováno v: PDA journal of pharmaceutical science and technology. 61(6)

During the period of 1998 to 2002, there was an increase in the incidence of antibody-positive pure red cell aplasia (PRCA) in patients receiving subcutaneous administration of EPREX (epoetinum alfa). As part of the investigation of this event, the a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::8628c926644e7a4ccccc45723c99a5f9
https://pubmed.ncbi.nlm.nih.gov/18410043

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