Hy's law

Hy's law is a rule of thumb that a drug is at high risk of causing a fatal drug-induced liver injury (DILI) when given to a large population, if it caused cases of liver injury that satisfied certain criteria when given to a smaller population. The law is based on observations by Hy Zimmerman, a major scholar of drug-induced liver injury.[1][2][3] Some have suggested the principle be called a hypothesis or observation.[4]

Hy's Law cases have three components:[1]

References

  1. 1 2 United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER): Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation, Final, July 2009
  2. "Use of Hy's law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury", Gastroenterology, pp. 109–118, July 2014, PMID 24704526
  3. "Use of Hy's Law, R criteria, and nR criteria to predict acute liver failure or transplantation in patients with drug-induced liver injury.", Gastroenterology, p. 148, Aug 2015, PMID 25532807
  4. "How can 'Hy's law' help the clinician?", Pharmacoepidemiology and Drug Safety, pp. 235–239, 22 March 2006


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