https://www.molward.com/knowledge.html Articles, guides and case studies on stability, degradation, nitrosamine/ICH M7 toxicology and method validation. en-us https://www.molward.com/knowledge-hed-mrsd-human-equivalent-dose-first-in-human-starting-dose.html https://www.molward.com/knowledge-hed-mrsd-human-equivalent-dose-first-in-human-starting-dose.html Toxicology & Safety Sun, 12 Jul 2026 09:00:00 +0000 How the FDA body-surface-area Km ratio converts an animal dose to the Human Equivalent Dose, and how the safety factor turns it into a defensible Maximum Recommended Starting Dose for a first-in-human trial. https://www.molward.com/knowledge-random-forest-qsar-early-genotox-screening.html https://www.molward.com/knowledge-random-forest-qsar-early-genotox-screening.html Toxicology & Safety Sat, 11 Jul 2026 09:00:00 +0000 How Random Forest algorithms reason over chemical topology, and why 2048-bit Morgan fingerprints trained on curated Hansen/ECVAM datasets beat legacy methods on ROC-AUC. https://www.molward.com/knowledge-beyond-the-black-box-regulatory-mechanistic-transparency.html https://www.molward.com/knowledge-beyond-the-black-box-regulatory-mechanistic-transparency.html Toxicology & Safety Fri, 10 Jul 2026 09:00:00 +0000 Why deep-learning models fail regulatory scrutiny without mechanistic explanations — and how ICH M7's dual expert-rule-plus-statistical architecture keeps AI-assisted toxicology defensible. https://www.molward.com/knowledge-preformulation-predicting-solid-state-and-degradation-risk.html https://www.molward.com/knowledge-preformulation-predicting-solid-state-and-degradation-risk.html Stability & Degradation Thu, 09 Jul 2026 09:00:00 +0000 Salt, polymorph and hygroscopicity choices made in preformulation quietly pre-programme your degradation profile — how to see the liabilities in silico before you commit the crystal form. https://www.molward.com/knowledge-setting-impurity-limits-ich-q3a-q3b-reporting-identification-qualification.html https://www.molward.com/knowledge-setting-impurity-limits-ich-q3a-q3b-reporting-identification-qualification.html Toxicology & Safety Wed, 08 Jul 2026 09:00:00 +0000 The ICH Q3A(R2)/Q3B(R2) dose-scaled threshold ladder, where the ICH M7 mutagenicity overlay overrides it, and how to justify each limit before an assessor asks. https://www.molward.com/knowledge-modified-release-dissolution-f2-similarity-control-strategy.html https://www.molward.com/knowledge-modified-release-dissolution-f2-similarity-control-strategy.html R&D Strategy Tue, 07 Jul 2026 09:00:00 +0000 A modified-release product's clinical behaviour lives in its release curve — how the f2 similarity factor turns that formulation fingerprint into a defensible, biowaiver-ready control strategy. https://www.molward.com/knowledge-stability-indicating-methods-sim-a-predictive-roadmap-for-analytical-chemists.html https://www.molward.com/knowledge-stability-indicating-methods-sim-a-predictive-roadmap-for-analytical-chemists.html Stability & Degradation Wed, 18 Mar 2026 09:00:00 +0000 Why waiting for a three-month stability pull to start method development is a business risk — and how to map the separation space before the first blank. https://www.molward.com/knowledge-the-cohort-of-concern-a-guide-to-high-risk-structures.html https://www.molward.com/knowledge-the-cohort-of-concern-a-guide-to-high-risk-structures.html Toxicology & Safety Fri, 13 Mar 2026 09:00:00 +0000 The three structural classes that lose the 1.5 µg/day safe harbour — and the process and excipient triggers that quietly generate them. https://www.molward.com/knowledge-study-case-predicting-late-stage-nitrosamine-degradation-and-automating-cpca-scoring-a-retrospect.html https://www.molward.com/knowledge-study-case-predicting-late-stage-nitrosamine-degradation-and-automating-cpca-scoring-a-retrospect.html Toxicology & Safety Thu, 12 Mar 2026 09:00:00 +0000 A retrospective look at the Zantac/NDMA recall: what a 43-second in silico scan would have flagged on Day 1. https://www.molward.com/knowledge-ich-m7-r2-compliance-when-do-you-actually-need-an-ames-test.html https://www.molward.com/knowledge-ich-m7-r2-compliance-when-do-you-actually-need-an-ames-test.html Toxicology & Safety Wed, 11 Mar 2026 09:00:00 +0000 A risk-based read of the Class 1–5 framework, and how a dual-methodology in silico assessment lets you defensibly skip the wet lab. https://www.molward.com/knowledge-navigating-the-2024-fda-nitrosamine-guidance-automating-cpca-limits.html https://www.molward.com/knowledge-navigating-the-2024-fda-nitrosamine-guidance-automating-cpca-limits.html Toxicology & Safety Sat, 07 Mar 2026 09:00:00 +0000 Decoding the Carcinogenic Potency Categorization Approach — and why manual α-hydrogen counting is a costly place to make an error. https://www.molward.com/knowledge-building-a-predictive-first-culture-in-pharmaceutical-r-d.html https://www.molward.com/knowledge-building-a-predictive-first-culture-in-pharmaceutical-r-d.html R&D Strategy Wed, 25 Feb 2026 09:00:00 +0000 Breaking down the wall between computational chemistry, formulation and the analytical lab with a single source of molecular truth. https://www.molward.com/knowledge-how-to-calculate-precision-and-intermediate-precision-in-method-validation.html https://www.molward.com/knowledge-how-to-calculate-precision-and-intermediate-precision-in-method-validation.html Method Validation Fri, 16 Jan 2026 09:00:00 +0000 Repeatability, intermediate precision, %RSD and the ANOVA F-test — the statistics that prove your stability data isn't just analytical noise. https://www.molward.com/knowledge-how-to-calculate-accuracy-in-method-validation.html https://www.molward.com/knowledge-how-to-calculate-accuracy-in-method-validation.html Method Validation Thu, 15 Jan 2026 09:00:00 +0000 Recovery studies, the three-level spiking protocol, and correcting impurity quantitation with Relative Response Factors. https://www.molward.com/knowledge-mass-balance-in-pharmaceutical-analysis-a-critical-stability-indicator.html https://www.molward.com/knowledge-mass-balance-in-pharmaceutical-analysis-a-critical-stability-indicator.html Stability & Degradation Thu, 15 Jan 2026 09:00:00 +0000 The AMBD and RMBD deficits, the five failing modes behind missing mass, and what regulators actually expect you to investigate.