Have you ever wondered why the same drug, same tablet, and same analytical test can have completely different requirements depending on how you are filing? This session answers that question in a clear, practical way that you can use immediately in your work. Rachna Chaddha from Eli Lilly will walk you through four key analytical activities like dissolution testing, method validation, stability testing, and impurity profiling and show you exactly what is required for NDA versus ANDA submissions, and why. Using real FDA deficiency examples, she will highlight the most common mistakes scientists make when switching between pathways and how to avoid them. You will leave with a straightforward, ready-to-use framework that takes the guesswork out of designing your analytical program — no matter which regulatory pathway you are on. If you work in analytical development, regulatory affairs, or pharmaceutical sciences, this is one session you do not want to miss.
Learning Objectives:
Describe how dissolution testing, method validation, stability programs, and impurity profiling requirements differ between NDA and ANDA submissions for oral solid dosage forms based on ICH guidelines and current FDA expectations.
Distinguish the scientific purpose and regulatory acceptance criteria for each analytical activity across NDA and ANDA pathways including f2 similarity testing, ICH Q2(R1) validation, ICH Q1A stability, and ICH Q3A and Q3B impurity requirements.
Apply a pathway specific analytical strategy framework to design dissolution, validation, stability, and impurity programs that meet FDA expectations and avoid common deficiencies in NDA and ANDA submissions.
.jpg "Rachna Chaddha, Masters in Analytical Chemistry (she/her/hers) photo")