Presented Thursday, September 17, 2020 with three sessions. Register below for the time that suits your location.
Demonstrating bioequivalence of topical products is a challenging task complicated by variations in drug formulations and testing methods, compounded by strict regulatory acceptance criteria. Having an appropriately validated IVRT/IVPT method is mandatory for product development and FDA and EMA approval. This challenge can be broken down into more manageable tasks by optimizing the critical factors involved in each stage of the testing process while keeping regulatory requirements firmly in mind. In this intermediate-to-advanced webinar, Theo Kapanadze, D.Sc., Ph.D. (Chemistry), Chief Science Officer of Diteba Laboratories, presents valuable insights into the use of proven IVRT and IVPT methods to obtain bioequivalence waivers for ointments, creams, gels, and ophthalmic formulations.
• New regulatory requirements defined by FDA and European Medicines Agency (EMA)
• FDA bioequivalence testing options and inherent risks, benefits, limitations of each
• Interpreting and applying FDA guidance documents
• Evaluation of in vitro release testing instrumentation, methods, and expected results
• Fundamentals of percutaneous absorption and in vitro permeation testing (IVPT)
• The impact of complete vs. partial receptor-media replacement
• Dealing with unconventional flux profiles
From this 45-minute presentation plus interactive Q&A session you will gain greater insight into the IVRT and IVPT systems and methods available today and how to more efficiently navigate the intricacies of obtaining bioequivalence waivers for a variety of topical products.
Thursday, September 17, 2020. Register (free) for the time that suits your location.
A video recording of the webinar is now available. Click here to watch.
The Teledyne Hanson Phoenix dry heat diffusion systems make diffusion‐cell testing faster, easier, and more economical. The Phoenix DB‐6 manual sampling system offers six‐cell manual sampling in a compact footprint with an advanced touch screen display. The Phoenix RDS Robotic Diffusion Station fully automates sampling, collection, and media replace with the ability to run up to 24 cells at once. Both systems rely on the new Phoenix™ dry heat diffusion cell, made from precision borosilicate glass, with mixer inserts engineered to produce instant homogenization of receptor media.