Small Molecule Testing: Expectations, Assessment & Strategies
Summary: Establishing a robust analytical method is an integral part of drug development’s lifecycle in ensuring the safety and efficacy of drug substance and product. There are several challenges in analytical method development and validation for small molecules, especially in relation to establishing appropriate characterization and control strategies to assess the quality of pharmaceutical products. Therefore, selecting the best risk assessment and analytical testing strategy is key to reducing process turnaround times and enable efficient submission of regulatory filings.
During this webinar, experts will share insights into current regulatory expectations on analytical test procedures for small molecules and provide recommendations for assessment, monitoring, and control of extractables and leachables (E&L) as well as genotoxic and elemental impurities, including nitrosamines. Join this webinar to explore risk-based approaches to reduce the burden of analytical testing without compromising patient safety.