Pharmacogenomics and Pharmacologic Class Effect in Drug Safety Management.

Autor: MIKYUNG KIM
Předmět:
Zdroj: Food & Drug Law Journal; 2014, Vol. 69 Issue 4, p603-623, 21p
Abstrakt: The article discusses the author's claim that following the approval of a drug by the U.S. Food and Drug Administration (FDA), pharmacogenomics can complement the use of pharmacologic class effects in drug-safety management by explaining the severity of adverse effects and drug interactions within a specific class of drugs. The FDA's regulation of new molecular entities (NMEs) is addressed in relation "Boxed Warning" (black box warning) labels. The practice of medicine is also examined.
Databáze: Supplemental Index