BCS Biowaiver — ICH M9

Screen a product for a BCS-based biowaiver against the ICH M9 decision tree: solubility (highest dose in ≤ 250 mL over pH 1.2–6.8), permeability (≥ 85 % absorbed), and dissolution of test vs reference in the three media — with f2 applied when needed. Class I and III can qualify; the tool tells you plainly when they don't, or when data are missing.

1 · Drug & classification

Highest single dose (mg)

Solubility @ pH 1.2 (mg/mL)

Solubility @ pH 4.5 (mg/mL)

Solubility @ pH 6.8 (mg/mL)

Permeability

High ⇔ ≥ 85 % absorbed.

Class III excipient assessment

Only used for Class III. Leave as “—” if unknown → inconclusive.

Narrow therapeutic index (excludes biowaiver)

2 · Dissolution — test vs reference in the 3 media

Time points (min) — shared by all media

Reference % dissolved

Test % dissolved

pH 1.2

pH 4.5

pH 6.8

Values comma- or line-separated, same count as the time points. ICH M9 requires all three media (pH 1.2, 4.5, 6.8).

3 · Result

Dissolution by medium

ICH M9 conditions

Computational screening of BCS-biowaiver eligibility against the ICH M9 criteria. Not medical or regulatory advice; the biowaiver decision and its full dossier (solubility/permeability studies, excipient justification, in vivo history) are the responsibility of the user's regulatory team.