Upcoming ABC Webinar: "Genotoxicity: Analytical Evaluation of Mutagenic Impurities"

Upcoming ABC Webinar:
Analytical Evaluation of Mutagenic Impurities
March 26, 12p CST
Presenter: Harley Everett Wilcox
Senior Scientific Advisor, ABC Laboratories

Impurity evaluations can take on a whole new level of specificity when mutagenic risk is present. Whether an evaluation is in support of clinical development, a marketing application, or post-commercial manufacturing changes, acceptance criteria often require parts-per-billion detection. On the other hand, “As Low as Reasonable Practicable” rules may not always apply. Misguided analytical strategies waste time and money. Many have left many promising development programs in limbo.

This webinar will address recent ICH M7 and other relevant guidelines that address genotoxic and carcinogenic potential. It also will discuss various genotoxic sources, including synthetic processes and impurities/degradation products, as well as relevant analytical testing methodologies.

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