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Degradation under control: Real-world case studies in pharmaceutical development (in Spanish)

9 am (Mexico – CST), 10am (Colombia – COT), 12 pm (Argentina – ART) Join us for this Spanish-language webinar where will guide you through real-life case studies using in silico tool Zeneth to solve stability problems at various stages of the drug development workflow. Case studies will include: Nitrosamine risk assessment Identification of degradants […]

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Nitrosamine control: Real-world applications of ICH M7 Options 3 & 4 (Korean)

니트로사민 관리 전략 – ICH M7 옵션 3 및 4의 실제 적용 Please note this webinar will be in Korean, or dubbed in Korean with Korean subtitles only. 15:30 (KST) In this webinar from Lhasa Limited and BITEK, we explore the scientific and regulatory challenges of applying ICH M7 Control Options 3 and 4 to

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Integrating ReproTracker into DART AOP Frameworks for mechanism-based teratogenicity assessment

Lhasa Limited Principal Scientist, Alun Myden, presented in webinar hosted by Toxys on the use of DART AOP frameworks for mechanism-based teratogenicity assessment.   Testing for developmental toxicity according to the current guidelines requires large numbers of animals. In addition to the ethical considerations and high costs of these traditional animal models, the outputs provide

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The evolving role of in silico tools in genotoxicity assessments

Regulatory frameworks like ICH M7 have established in silico tools as a trusted method for evaluating the mutagenic potential of impurities, reducing reliance on animal testing and accelerating risk assessments. While these tools are widely accepted for mutagenicity, researchers and regulators are now looking at their potential for broader genotoxicity evaluations, including chromosome damage. As

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How to establish acceptable intake limits for NDSRIs (in Japanese)

Our webinar ‘How to establish acceptable intake limits for NDSRIs’ was hosted in Japanese and contains pre-recorded videos with Japanese subtitles. This virtual event lasted approximately 2 hours. Nitrosamine Drug Substance-Related Impurities (NDSRIs) have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to

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Read-across masterclass: How to facilitate your acceptable intake limit setting for nitrosamines

Read-across is a popular data gap filling technique which has recently gained recognition in regulatory guidance as a valuable tool for identifying suitable surrogates in establishing Acceptable Intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). We held an informative webinar where we unveiled Acrostic, our novel read-across solution designed to facilitate decision-making when determining

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Identifying the formation of nitrosamines via degradation pathways using an in-silico approach

Ensuring the safety of active pharmaceutical ingredients (APIs) is of great importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. Our in silico tool Zeneth has been used within exploratory formulation departments to understand and account for potential degradation problems within the API at an early stage, resulting

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Leachables sensitisation assessment framework in collaboration with ELSIE

This enlightening event brought together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitisation potential of extractables and leachables (E&Ls). Featured presenters and ELSIE consortium members included: Patricia Parris, Global Risk Assessment Services Toxicologist at Pfizer Geraldine Whelan, Regulatory Toxicologist at GSK Martyn Chilton, Principal

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