ICH M13B Strength Biowaiver

ICH M13B is covering additional strengths biowaivers of immediate-release solid oral dosage forms. The guideline explains the condition in which bioequivalence studies can be waived for one or more extra strengths if bioequivalence has already been established in vivo for at least one strength, in general the highest possible strength. The present webinar will focus on when strength biowaiver could be applied and on the requirements for additional strengths.

• Identify when a strength biowaiver can replace an in vivo bioequivalence study
• Apply ICH M13B requirements for qualifying additional immediate-release strengths

Clinical Pharmacologists, Formulation Scientists, Pharmacokineticists