Bioequivalence Studies

BIOEQUIVALENCE STUDIES

Bioequivalence, pharmacokinetics, biowaiver, in vitro dissolution, generics

PHA FARMED provides the services as requested in applications for generic medicinal products according to Directive 2001/83/EC, Article 10(1), bioequivalence with the reference medicinal product shall be demonstrated by appropriate bioavailability studies for demonstrating of bioequivalence, including variations, fixed combinations, extensions and hybrid applications.

Study design, selection of subjects, study conduct and evaluation of bioequivalence studies

Obtaining reference products
Comparative bioavailability studies
Waiver
BCS based Biowaiver
Pharmacodynamic or clinical endpoints
CHMP Scientific Advice
Full study reports: study report synopses for bioequivalence or comparative bioavailability studies
Bioanalytical testing GLP
Statistical analysis