CRED 8 Presentations

03/07/2024

Quality (impurities) Quantitative compositions

Comparable Impurity Profiles

Comparable Dissolution Profiles

The Organisation for Professionals in Regulatory Affairs

15

Bioequivalence

• The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product

• Comparator (reference product) to use • Linear pharmacokinetics over the usual dosage range • Strength of product to use • Test product batch (biobatch is a representative batch) • Safety to the subjects (patients or volunteers) • Food effect / Fasting or fed • Single dose or steady state • Variability of the drug (intra and inter subjects) • Narrow therapeutic range • Statistical considerations / number of subjects • Enantiomer-specific / metabolite / pro-drug measurement • Bioanalytical assay sensitivity

The Organisation for Professionals in Regulatory Affairs

16

8