Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification
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.
Assessing the Impact of Expert Knowledge on ICH M7 (Q)SAR Predictions
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.
Applying Expert Knowledge for ICH M7 Impurity Classification – Session 3
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 another intriguing case study.
Applying Expert Knowledge for ICH M7 Impurity Classification – Session 2
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 1
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.