Applying Expert Knowledge for ICH M7 Impurity Classification - Session 1

9 June 2020 | MultiCASE's Dr. Suman Chakravarti delves into the comprehensive scope of the ICH M7 guideline, which plays a crucial role in impurity classification. The video not only presents a clear understanding of the guideline but also provides practical insights through basic case studies, featuring common examples of expert reviews.

Applying Expert Knowledge for ICH M7 Impurity Classification - Session 2

7 July 2020 | In Session 2 of our 3-part series, we bring you two insightful presentations that delve into intriguing case studies, shedding light on the crucial factors that influence impurity classification and guide future actions. Alejandra Trejo-Martin from Gilead Sciences takes the stage in Presentation 1, sharing in-depth analysis and expertise. Sebastian Joseph from Pharmalex India follows with Presentation 2, offering valuable insights into various classification considerations.

Applying Expert Knowledge for ICH M7 Impurity Classification - Session 3

4 August 2020 | In Session 3, we dive deep into case studies featuring conflicting results, making it a fascinating exploration of impurity classification. Aldo Coppi from Amgen shares his scientific expertise, providing detailed insights into a compelling case study. Then we have the privilege of learning from the accomplished Dr. Ravichandra BV, Lead Toxicologist at Dr. Reddy's Laboratories, who presents yet another intriguing case study.

Assessing the Impact of Expert Knowledge on ICH M7 (Q)SAR Predictions

22 November 2021 | Dr. Naomi Kruhlak from the US FDA CDER presents a recent study that delves into the impact of expert review on (Q)SAR predictions. The study's findings reveal the rates of overturned calls, the specific categories (equivocal/positive or equivocal/negative) to which they belong, and the chemical classes most affected by the application of expert review.

Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

12 March 2022 | Dr. Naomi Kruhlak provides a comprehensive overview of (Q)SAR methodologies used to determine ICH M7 Classification from the esteemed perspective of the US FDA. Throughout the presentation, Dr. Kruhlak covers a range of topics, starting with the question of why (Q)SAR is an invaluable tool for assessing drug impurities. She then delves into the basics of (Q)SAR, including model building and the concept of applicability domain.

Carcinogenicity Assessment of Nitrosamines: Current Status

19 July 2023 | Dr. Suman Chakravarti from MultiCASE unveils the latest updates to nitrosamine classification in alignment with the recent publications by EMA/CMDh. Dr. Chakravarti also shares insights into the upcoming modifications to MultiCASE's QSAR Flex software, specifically designed to support these new guidelines.

QSAR Models for Endocrine Disruption

1 August 2023 | MultiCASE's Mounika Girireddy explores the cutting-edge world of QSAR models tailored for assessing endocrine disruption potential in various substances. The session provides a comprehensive overview of QSAR's foundations and its application in predicting complex endpoints related to endocrine disruption. We delve into various refined in vitro assays and innovative layered modeling techniques that optimize predictions by combining in vivo and in vitro data.