During this presentation, Lora Killian, Synchrogenix Director of Transparency and Disclosure, discussed complications caused by the requirements outlined in the guidance document, EMA Policy 70, and proposed some solutions.
There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of those suffering from rare diseases, represents a huge unmet medical need. Modeling and simulation approaches are not only ideal for the development of drugs for rare diseases, but are encouraged by regulators.
This webinar discussed best practices for sharing plain language trial results as a foundation for helping ensure that patients who give the gift of study participation have the opportunity to understand their contribution to advancing medical science.
Watch this webinar with Certara’s Dr. Nathan Teuscher to learn more about the amazing features and enhancements now available in Phoenix 7.0.
In this webinar, Dr. Adam Darwich, Certara Lecturer in Precision Dosing at the Manchester Pharmacy School at The University of Manchester, presented several case studies that illustrate how PBPK models have been used to predict drug-drug interactions, extrapolate to special populations, and optimize clinical study design.
