Interpreting ICH Q3A and Q3B impurity guidelines
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Interpreting ICH Q3A and Q3B impurity guidelines
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Un Farmacéutico on Instagram: "“EMA 2026: How to Qualify Non-Mutagenic Impurities (NMIs) with Exposure, Read-Across & NAMs (Avoiding Unnecessary In Vivo)” -- In this video, I break down the EMA CHMP Reflection paper (2026) on the qualification of non-mutagenic impurities (NMIs)—a practical framework for situations where a new impurity emerges or an impurity level increases above ICH Q3A/Q3B qualification thresholds, especially post-approval when a full nonclinical package is no longer realistic.
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EMA 2026 : Qualifier les impuretés non mutagènes (NMIs) — Exposition, Read-across & NAMs plutôt que l’in vivo inutile -- Dans cette vidéo, je décrypte le Reflection paper du CHMP/EMA (2026) sur la qualification des impuretés non mutagènes (NMIs), particulièrement utile lorsque de nouvelles impuretés apparaissent ou qu’une impureté augmente au-delà des seuils de qualification ICH Q3A/Q3B, notamment après l’autorisation (post-approval). Vous découvrirez le workflow progressif proposé par l’EMA, al
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EMA 2026: Qualificare le impurezze non mutagene (NMIs) — Esposizione, Read-Across e NAMs (evitando in vivo non necessari) -- In questo video analizzo il Reflection paper del CHMP/EMA (2026) sulla qualificazione delle impurezze non mutagene (NMIs), particolarmente utile quando compare una nuova impurezza o un’impurezza aumenta oltre le soglie di qualificazione ICH Q3A/Q3B, soprattutto in scenari post-approval. Vedremo il workflow stepwise proposto dall’EMA, in linea con le 3Rs, che privilegia: ra
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