Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations

An important safety consideration for developing new therapeutics is assessing the potential that the therapy will increase the risk of cancer. For biotherapeutics, traditional two-year rodent bioassays are often not scientifically applicable or feasible. This paper is a collaborative effort of indu...

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Veröffentlicht in:Toxicologic Pathology 2010-06, Vol.38 (4), p.522-553
Hauptverfasser: Vahle, John L., Finch, Gregory L., Heidel, Shawn M., Hovland, David N., Ivens, Inge, Parker, Suezanne, Ponce, Rafael A., Sachs, Clifford, Steigerwalt, Ronald, Short, Brian, Todd, Marque D.
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