Dr. Soula Kyriacos, Associate Professor and consultant to the pharmaceutical industry; Dr. Aline Milane, Associate Professor at the LAU School of Pharmacy; and Dr. Sam Haidar, Executive Director of the LAU Khayrallah Center, conducted a scientific and regulatory workshop at Algorithm SAL, one of Lebanon’s largest pharmaceutical manufacturers, with a presence in several countries in the Middle East and North Africa.
The workshop covered an introduction to bioavailability and bioequivalence (BE), bioanalytical method validation and study sample testing (ICH M10), Good Clinical Practice (ICH E6), BE study design (ICH M13), regulatory perspectives on BE testing, pharmacokinetics and biostatistical analysis of BE studies, and drug product dissolution and biowaivers.
A similar workshop was successfully conducted at Benta Pharma Industries by the presenters above.
