publication . Other literature type . Article . 2019

Regulatory Requirements of the European Medicines Agency for Evaluation of Bioequivalence of Modified-release Medicinal Products

Open Access
  • Published: 01 Mar 2019
  • Publisher: SCEEMP
Abstract
<jats:p>There are no specific requirements and recommendations in the Russian Federation for evaluation of bioequivalence of modified-release medicinal products. Until recently, modified-release products were regulated in a similar manner as immediate-release products, which is unacceptable considering the active ingredient release profile and its pharmacokinetics. The modified release characteristics require a more complex approach to the assessment of equivalence of generic medicines as compared with the reference product. The number of parameters to be assessed and the scope of testing depend on many factors (release mechanism, specific features of the dosage...
Persistent Identifiers
Subjects
free text keywords: bioequivalence, bioequivalence studies, generic medicines, prolonged release, delayed release, european medicines agency (ema), lcsh:Medicine (General), lcsh:R5-920, Dosage form, Active ingredient, Risk analysis (engineering), Business, Ingredient, Authorization, Reference product, Russian federation, Food intake
Any information missing or wrong?Report an Issue