Bioequivalence Study Design: Crossover vs Replicate vs Parallel, Sample Size and Acceptance Criteria
How to choose a bioequivalence study design: crossover, replicate and parallel designs, what drives sample size, and current FDA, EMA and ICH M13 criteria.
PBPK Modeling in Generic Drug Development: How It Works and When Regulators Accept It
What PBPK modeling is, how a PBPK model is built and verified, how it differs from popPK and QSP, and what FDA, EMA and ICH M15 weigh before relying on it.
ICH M10 Bioanalytical Method Validation: Requirements, Acceptance Criteria and What Changed from FDA 2018
ICH M10 explained: bioanalytical method validation criteria for chromatographic and ligand binding assays, study sample rules, and what changed from FDA 2018.
Nitrosamine Risk Assessment: A Step-by-Step Guide for Generic Manufacturers
How to run a nitrosamine risk assessment: risk factors to check, when to test, how to structure the report, and where SFDA and EMA expect it in the dossier.
What Are NDSRIs? Nitrosamine Drug Substance-Related Impurities Explained
What NDSRIs are, how they form, how FDA and EMA set NDSRI acceptable intake limits with the CPCA, and what testing and control regulators expect.