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Keywords:

  • drug-induced;
  • prolactin;
  • hypoprolactinemia;
  • hyperprolactinemia;
  • risk assessment

ABSTRACT

Drug-induced changes in prolactin signaling may obscure interpretation of preclinical toxicological endpoints. However, with informed consideration, classic hallmarks of hypo-/hyperprolactinemia can be recognized in short- and long-term rodent bioassays. Findings can be supported and expanded with additional in vivo and in vitro datasets. When taken together with human epidemiological evidence pertaining to the consequences of drug-induced hypo-/hyperprolactinemia, such findings permit both an analysis of human relevance and an assessment of human risk. Copyright © 2011 John Wiley & Sons, Ltd.