Скачать или смотреть AGDD 2024 | D1S04 - Application of Adaptive Perfusion as In Vitro Release Testing Method...

This presentation explored the critical need for improved In Vitro Release Testing (IVRT) methods for complex drug products. The session outlined current challenges and unmet needs in IVRT methodology, followed by discussion of internal approaches developed to address these issues. The presentation featured adaptive perfusion (AP) as an innovative solution and included a detailed case study on ophthalmic emulsion testing. Additional potential applications for these advanced IVRT methods were also examined, providing insights into future directions for complex pharmaceutical product testing.

Timestamps

01:08 – Common IVRT Methods

05:50 – Challenges with Current IVRT Method

06:08 – How can we improve IVRT?

09:37 – Case Study: Formulation with Varying Globule Size Distribution

14:26 – Summary

Speaker:

Dongkai Zhu, PhD
Visiting Associate
Division of Pharmaceutical Quality Research VI (DPQR VI)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ) | CDER

Learn more at: https://www.fda.gov/drugs/news-events...

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