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
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Meet the Expert: Dr. Anne Ries | Explore a practical benchmark example comparing two icIEF instruments, and gain a reusable framework to support lifecycle management of analytical methods in regulated environments.
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
On-Demand Presentation by Dr. Anne Ries (Boehringer Ingelheim) | Discover how historical QC control chart data can replace prospective experiments on the old instrument to set statistically robust acceptance criteria, illustrated through a real-world icIEF platform transition across multiple commercial products.
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