Bevezetés az in-vitro hatóanyag-leadás vizsgálatokba

A Teledyne Hanson Research a németországi  RaDes GmbH-val együttműködve 2021. június 9-én “Introduction to IVRT: Fundamentals of In Vitro Release Testing of Semisolid Dosage Forms” webinart tart.

Az angol nyelvű, kb 45 perces előadáson és az azt követő azonnali kérdések-és-válaszokon való részvétel ingyenes, de regisztrációhoz kötött. A webinar témái és a meghirdetett időpontokon való regisztrációs lehetőségek a következők:

Europe

14:00 / 2 PM CEST
7:00 AM in CST (US and Canada)

The Americas

20:00 / 8 PM CEST
1:00 PM in CST (US and Canada)

Asia/PacRim

3:00 / 3:00 AM CEST, June 10
8:00 PM in CST (US and Canada)

REGISTER REGISTER REGISTER

 

Evaluating release characteristics of active pharmaceutical ingredient (API) from a semisolid dosage form, whether for product development or quality control purposes, is best accomplished using vertical diffusion cell (VDC) instruments and methods. Obtaining test results that are meaningful for product development and acceptable by regulatory agencies requires a strong understanding of the factors affecting the accuracy and precision of in vitro release testing (IVRT). In this introductory-level webinar moderated by Keith Hamman, Vice President & General Manager of Teledyne Hanson, RaDes GmbH’s Sascha Gorissen, Lab Operations Manager, and Michael Herbig, CEO, will provide details on IVRT methods and best practices to ensure high quality results that fully comply with industry guidance, such as USP <1724> Semisolid Drug Products – Performance Tests.

Topics of discussion:

        • What is diffusion and how is it calculated?
        • Release test (IVRT) vs. permeation test (IVPT)
        • IVRT receptor cell media and “back diffusion”
        • IVRT test setup: membrane selection
        • Determining API release rate
        • IVRT method validation: sensitivity, linearity, specificity, and robustness
        • Data validation: two-stage comparison testing of reference drug (R) vs. test formulation (T)