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Why Applicability Domain Matters in (Quantitative) Structure-Activity Relationship (Q)SAR Models: Supporting Interpretation in Mutagenicity Assessments
Understand how applicability domain affects QSAR prediction confidence and why chemical coverage matters when assessing pharmaceutical impurities under ICH M7.
Inspection Week Shouldn’t Feel Like A Fire Drill
Regulatory inspections shouldn’t require weeks of searching for records, rebuilding audit trails, and pulling teams away from their day-to-day work. This blog explores why organisations are moving from reactive inspection preparation to continuous compliance, and...
Beyond the PPD Label: Clearer Language for Stronger Clinical Trial Transparency Submissions
In this blog, we discuss PPD, what different agencies actually care about, and how to navigate CTT language in an ever-changing regulatory landscape.
What’s New in eQCM 10.01?
With the release of eQCM 10.01, Instem is introducing tighter document control and audit trail integrity for regulated environments.
Introducing Blur™ 2.10: Faster, More Precise Clinical Trial De-Identification
With the release of Blur™ 2.10, Instem is introducing a broad set of enhancements across CSR anonymization, data de-identification, risk simulation, administration, performance, and security.
Mutagenicity Assessment Under ICH M7: Scientific Principles Supporting Pharmaceutical Impurity Risk Assessment
Mutagenicity assessment is the critical first step in pharmaceutical impurity risk evaluation, and this blog explores the scientific principles underpinning robust ICH M7 assessments, from complementary QSAR methodologies and Ames study data to applicability domain...
インシリコによる知見を活用したCMC対応体制の強化
CMCの準備は、IND申請のかなり前から始まります。医薬品開発の全過程において、早期のデータ駆動型意思決定、予測毒性学、および連携されたワークフローが、いかにしてリスクを低減し、データ品質を向上させ、規制対応の準備を簡素化できるかについてご紹介します。
ウェビナーのまとめ：SENDの品質が最も重要となる時
先日開催されたウェビナー「SENDの品質が最も重要となる時」では、データ品質に関するFDAの最近の発表、規制当局の期待が変化している理由、よくある問題点がどこで発生するか、そして組織がSENDデータセットを提出する前に信頼性を高める方法について考察しました...
