The International Conference on Harmonisation came close to completing its planned adoption of a proposed M9 biowaivers guideline at its June meeting in Amsterdam, Roger Nosal of Pfizer Inc., told the recent Drug Information Association annual meeting in San Diego, California.
M9 Biowaivers Guidance Nearly Harmonised During ICH Meeting
Experts came close to harmonizing draft ICH M9 guidance on biowaivers, which allow in-vitro in lieu of in-vivo bioequivalence testing under certain circumstances. Final guidance is expected soon, Drug Information Association annual meeting told.
