Pharmaceutical equivalence

The pharmaceutical equivalence of two drugs is given if they contain the same drug in the same molar amount ( dose ), have the same dosage form and meet the same quality standards. A distinction in characteristics such as shape, color and taste, etc. is permitted. Bioequivalence cannot necessarily be derived from pharmaceutical equivalence , since the drugs can differ in their release behavior .

Individual evidence

↑ Guideline on the Investigation of Bioequivalence. (99KB PDF) The European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use (CHMP), January 20, 2010, accessed on August 6, 2011 .

[1] Guideline on the Investigation of Bioequivalence. (99KB PDF) The European Agency for the Evaluation of Medicinal Products, Committee for Medicinal Products for Human Use (CHMP), January 20, 2010, accessed on August 6, 2011 .