ICH Q1E shelf life calculation from accelerated stability data: the method, a worked example with real Arrhenius output, and when extrapolation is not OK.
June 8, 2026
Insights
Insights
Articles for analytical, QC and CMC teams: spectra, impurities, stability, ICH M7 and HPLC, each with a worked example.
All articles
Guide8 min read
ICH Q1E Shelf Life Calculation from Accelerated Data
Explainer7 min read
OOT vs OOS in Stability Data: Catching Drift Early
Out of trend stability data explained: how OOT differs from OOS, when regression, CUSUM and Shewhart methods fire, and a worked example.
June 7, 2026
Comparison8 min read
Screening Designs Compared: Fractional, PB and DSD
Screening design comparison: fractional factorial vs Plackett-Burman vs definitive screening, with run counts, resolution and power from real calculations.
June 5, 2026
Explainer8 min read
PBT Assessment for Pharmaceuticals: Very Toxic Is Not PBT
PBT assessment for pharmaceuticals: how P, B and T differ from GHS aquatic hazard, with real ecotox results for three drug molecules.
June 3, 2026
Explainer7 min read
DoE Residual Diagnostics: Shapiro-Wilk and Cook's D
DoE residual diagnostics explained: what Shapiro-Wilk, Cook's distance and leverage actually tell you about an RSM fit, on a real central composite design.
June 2, 2026
Explainer8 min read
Retention Time Prediction in HPLC Method Development
What retention time prediction in HPLC is actually good for, what it is not, and a worked impurity panel with real predictions.
June 1, 2026
Use case8 min read
Immunogenicity Prediction for Antibodies: MHC-II Screening
Immunogenicity prediction for antibodies: how MHC-II epitope screening works, real results on trastuzumab VH/VL, and what in-silico ADA risk cannot.
May 28, 2026
Comparison8 min read
Central Composite vs Box-Behnken: Which Design, When
Central composite vs Box-Behnken on the same 3 factors: real run counts, axial points, power and the corners each design does not visit.
May 27, 2026
Explainer8 min read
Cpk vs Ppk: In Control Is Not the Same as Capable
Process capability for pharma: what Cpk and Ppk actually measure, why a stable process can still miss target, and a worked example with real SPC.
May 26, 2026
Use case8 min read
ICH M7 triage on the losartan example: two methods, one expert review
ICH M7 requires two (Q)SAR methods per impurity. On a Losartan worked example: 10 impurities classified in seconds, 5 probable mutagens identified, including the well-known azido impurity (AZBT). How both methods come together, and where the limits are.
May 24, 2026
Use case9 min read
Estimating shelf life with Arrhenius: what accelerated data can tell you
From a few weeks of accelerated stability data to a shelf-life estimate in minutes: on an amoxicillin example. Why the limiting parameter is not assay. And why the analysis itself tells you when not to rely on extrapolation alone.
May 24, 2026
Benchmark10 min read
Can toxicity be predicted? The toxicity benchmark, measured honestly
Our toxicity prediction covers the common ADMET and toxicity endpoints. In a direct comparison against the TDC leaderboard, we sit a few points below the best dataset-specialized models on the AUROC endpoints. We name the weak spots openly.
May 24, 2026
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