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Practical preclinical model for assessing the potential for unconjugated hyperbilirubinemia produced by human immunodeficiency virus protease inhibitors
Authors:Kempf Dale J  Waring Jeffrey F  Morfitt David C  Werner Paige  Ebert Brian  Mitten Michael  Nguyen Bach  Randolph John T  DeGoey David A  Klein Larry L  Marsh Kennan
Affiliation:Global Pharmaceutical Research and Development, Abbott, Abbott Park, Illinois 60064, USA. dale.kempf@abbott.com
Abstract:A practical preclinical model for the hyperbilirubinemia produced by human immunodeficiency virus protease inhibitors has been developed. Indinavir and atazanavir produced significant hyperbilirubinemia, whereas amprenavir, the negative control, was indistinguishable from the ritonavir booster dose. This model was used to disqualify an exploratory protease inhibitor from development.
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