Consult Lhasa

What a productive Society of Toxicology (SOT) 2025 we had! ?? A huge thank you to everybody who attended our booth and exhibitor-hosted sessions on #carcinogenicity assessments and #ReadAcross. It was great to see such a full and engaged audience for both sessions. If you missed the presentations and would like a copy of the slides, please reach out to us at marketing@lhasalimited.org. We wish everybody a safe journey home ?? #2025SOT #SOT2025

Are you at Society of Toxicology (SOT) this week? ?? Swing by booth 1500 if you'd like to discuss: ??Impurity formation ??Mutagenic impurities ??Non-mutagenic impurities ??Nitrosamines

?? What you need to know about RDC 964/2025. ANVISA recently published new, more rigorous guidelines for forced degradation studies in drug products. These include: ?? ?????????????? ???????????????????? ?????????????????????????? – Specifies the analytical methods and stress parameters required to assess drug stability under various environmental conditions. ?? ?????????? ???????????????????? ???? ?????????? ???????????????????????? – Mandatory studies for new drug registrations, API composition changes, and post-registration variations. ?? ???????????????? ?????????????????????????? ???????????????? – Greater need for technical justification when requesting exemptions from degradation studies under specific conditions. ?? ???????????????? ???????????????????? ???????????????????? – More detailed requirements for validating stability-indicating analytical methods, including chromatographic purity assessment. ?? ???????? ?????????????? ???????????????????????????? – Justifications now required for deviations in mass balance calculations. How can we help? ? Consult Lhasa can provide a comprehensive API degradant profile proving to regulators that your forced degradation study methods are suitable and realistic, explaining any mass imbalances, with scientific justification. ? We can also provide an overview of the compatibility of your API with excipients under stress conditions when considering your drug product formulations, and support in the evaluation of API composition changes when required. ?? Get in touch for expert guidance: https://buff.ly/uSeFNO8

At Consult Lhasa, we are committed to positively impacting human health by enhancing scientific risk assessments. Our team of multilingual scientific consultants ensures that our services are accessible worldwide. Discover more about our purpose: https://buff.ly/X6xSiuh

ANVISA has published RDC 964/2025, introducing more rigorous guidelines for forced degradation studies in drug products. This replaces RDC 53/2015 and RDC 171/2017, strengthening impurity assessment and risk analysis. What’s New? ?? Defined Analytical Methodologies – Specifies the analytical methods and stress parameters required to assess drug stability under various environmental conditions. ?? Clear Guidelines on Study Requirements – Mandatory studies for new drug registrations, API composition changes, and post-registration variations. ?? Stronger Justification Criteria – Greater need for technical justification when requesting exemptions from degradation studies under specific conditions. ?? Enhanced Analytical Validation – More detailed requirements for validating stability-indicating analytical methods, including chromatographic purity assessment. ?? Mass Balance Considerations – Justifications now required for deviations in mass balance calculations. How Can We Help? ? Consult Lhasa can provide a comprehensive API degradant profile proving to regulators that your forced degradation study methods are suitable and realistic, explaining any mass imbalances, with scientific justification. ?We can also provide an overview of the compatibility of your API with excipients under stress conditions when considering your drug product formulations, and support in the evaluation of API composition changes when required. ?? Get in touch to discuss how we can support you with the regulatory changes: https://bit.ly/41erCWO

?? Do you need help evaluating the level of elemental impurities in your final drug product? Elemental impurities (EIs) can originate from several sources and need to be controlled to a safe limit. At Consult Lhasa, we help assess the risk of EIs in your final drug product, relative to the permitted daily exposure (PDE), in line with the ICH Q3D guidance. If necessary, based on the risk assessment outcome, we can propose a control strategy. ?? Get in touch for expert guidance and to learn more: https://buff.ly/41dINI0

Are you looking for regulatory support? We can help. At Consult Lhasa, our expert scientific consultants are here to support your risk assessments, ensuring safe final drug products and helping you meet regulatory requirements. Find out more and get in touch: https://buff.ly/4beuPdK #pharmasafety #riskassessment #drugdevelopment #chemicalsafety

Have you seen the European Medicines Agency's latest draft Reflection Paper on the qualification of non-mutagenic impurities? The update introduces a proposed workflow for impurity qualification, allowing API-like impurities to be qualified using in silico tools, as well as read-across and an integrated risk assessment based on weight of evidence (WoE). At Consult Lhasa, our scientific consultants are experts in these approaches and use Lhasa Limited in silico predictions to improve scientific risk assessments. ?? Get in touch and find out how we can support you: https://buff.ly/3X3Aeyl

2024 was an exciting year for Consult Lhasa, made possible by the dedication of our team and collaborators across the globe ??. Join the conversation below as Crina Heghes, CEO of Consult Lhasa and Social Media Partner, Joshua Cosby reflect on key highlights and look ahead to 2025 ???. Discover more: https://buff.ly/3EliXtT

Do you need support in assessing a residual solvent not listed in ICH Q3C? ?? If a solvent is not included within the ICH Q3C guidelines, we can perform a permitted daily exposure risk assessment to establish an acceptable limit (AI), if relevant and robust data exists. ??When high-quality data for your residual solvent is unavailable, the correct analogue – or class of analogues – must be identified. Where possible, we will provide appropriate read-across analogues and utilise them to establish an AI for your solvent. Discover more: https://buff.ly/4jFFUIh