M13A is the first guideline in this series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms.1) highly 50 variable drugs,
Study designs containing multiple comparator or test products are included for some initial steps in reducing the associated burden without bias toward the regional legal requirements.
The second guideline in the series, M13B, will describe biowaiver considerations for additional 48 strengths not investigated in BE studies.
The third guideline in the series, M13C, will include data analysis and BE assessment for:
2) drugs with a narrow therapeutic index,
3) complex BE study design and data 51 analysis considerations.