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Presenter: non‑high‑risk products generally need one fasting BE study; high‑risk products need fasting and fed studies
Summary
The presenter explained typical BE study choices under ICH M13A: non‑high‑risk products usually require a single fasting study while high‑risk products typically require both fasting and fed BE studies because fasting results may not predict fed conditions.
The presenter described recommended BE study approaches under ICH M13A. For non‑high‑risk products (typically highly soluble and noncomplex formulations), the recommendation is usually a single BE study, most often conducted in fasting conditions. She noted exceptions exist when safety or PK variability justify an alternative (for example, a fed study instead of fasting).
For high‑risk products the presenter said FDA generally recommends both fasting and fed BE studies because differences in formulation or drug properties can produce differing in vivo outcomes across nutritional states; fasting studies alone may not reveal food‑dependent performance issues.
