Non-Procrustean pathways for complex generic drugs development

Ther Deliv. 2018 Sep;9(9):605-607. doi: 10.4155/tde-2018-0047.
No abstract available

Keywords: bioequivalence; complex generics; model-informed drug development; modeling and simulation.

Publication types

  • Editorial

MeSH terms

  • Drug Development / legislation & jurisprudence*
  • Drug Development / standards
  • Drugs, Generic / administration & dosage
  • Drugs, Generic / pharmacokinetics*
  • Equivalence Trials as Topic
  • Guidelines as Topic
  • Humans
  • Therapeutic Equivalency

Substances

  • Drugs, Generic