Expert Insight & Answers | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria accordingly.
Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
On-Demand Presentation | Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing Understand the practice surrounding post-approval method changes and its impact on compliance Identify when pharmacopoeial methods are necessary and when alternative validated methods may be used Gain practical insights into testing comparability between methods and replacing existing methods or instrumentation
Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles
On-Demand Presentation by Dr. Francisca Galindo Garre (Johnson & Johnson Innovative Medicine) | Compare qPCR and capillary electrophoresis head-to-head and gain the statistical toolkit, from equivalence testing to correlated variance regression, to make defensible method interchangeability decisions.
Advertisement
Advertisement
Advertisement






