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Este webinar mostró cómo integrar la evaluación predictiva, el establecimiento de la ingesta aceptable y la confirmación analítica para tomar decisiones más claras y mejor fundamentadas durante todo el proceso de gestión del riesgo asociado a nitrosaminas. Identificar un posible riesgo asociado a nitrosaminas es solo el comienzo. Lo que sigue es determinar si su

Perspectivas prácticas basadas en evaluaciones in silico, casos de estudio de la industria y evidencia analítica La incompatibilidad API-excipiente representa uno de los principales riesgos evitables en el desarrollo farmacéutico temprano. En este webinar, exploraremos cómo las herramientas in silico pueden ayudar a identificar estos riesgos con mayor anticipación, antes de invertir tiempo y recursos

This webinar brings together the authors of two recently published papers to walk through their findings, discuss methodology, and explore what their work means for nitrosamine risk assessment in practice. Hosted by Lhasa Senior Scientist Gem Packer, the session will cover how in silico tools and industry data sharing are being applied to identify and

How do you build a defensible extractables and leachables (E&L) justification when the data is incomplete? As the ICH Q3E guideline develops, expectations for E&L risk assessment are becoming clearer, particularly around how safety thresholds are derived and how decisions are justified when evidence is limited. This webinar focused on how these expectations translate into

This webinar is a replay designed for our Japanese-speaking scientific community, with presentations available as recordings featuring embedded Japanese subtitles. The ICH S1B(R1) addendum is a globally recognised guideline that introduces a weight-of-evidence (WoE) approach to assessing the carcinogenic potential of pharmaceuticals.  It helps pharmaceutical organisations determine whether a two-year rat carcinogenicity study would provide

強制分解の問題解決 This session was hosted in Japanese or with Japanese subtitles. Supporting forced degradation studies with in silico tools as part of your workflow. Hosted by Business Partnerships Satoshi Mashiko, with Senior Scientist Jonathan Lockett, this session covered four case studies demonstrating how in silico solution Zeneth can support confident interpretation of forced degradation studies and subsequently

Thursday 11th December 13:00 – 15:00 (BRT) This webinar was delivered entirely in Portuguese. Are you looking to strengthen your understanding of the ICH M7(R2) guideline and learn practical approaches to conducting compliant impurity risk assessments? This live webinar, delivered fully in Portuguese, explored how the ICH M7 framework supports the assessment and control of

This webinar was prepared for the Japanese-speaking scientific community. Presentations were delivered in English, with Japanese subtitles provided. It was designed for scientists, researchers, and regulatory professionals who want to strengthen their understanding of the ICH M7 guideline and its impact on the classification of mutagenic impurities. Catch up on the webinar recording, to: Gain

Predicción de productos de degradación: Herramientas in silico para el desarrollo analítico We were delighted to host this Spanish-language webinar tailored toward analytical chemists based in Latin America. We introduced the concept of theoretical degradation prediction and run through some case studies relating to: – Structural elucidations of unknowns – Rationalising the formation of nitrosamines

We held this portuguese-language webinar all about supporting forced degradation studies with in silico tools as part of your workflow. With Scientist Meire Kawamura and Senior Global Alliances Manager Diego Gomes, this session will cover four case studies demonstrating how in silico solution Zeneth can support confident interpretation of forced degradation studies and subsequently result in