Solving a Mystery Using PBPK: How Drug-excipient Complexes Can Confound a Metabolic DDI Result

Assessment of drug-drug interaction (DDI) liabilities is an important safety component of any drug development program. Itraconazole, a selective strong inhibitor of CYP3A, has been widely employed to determine the maximum drug interaction risk with new molecular entities as CYP3A substrates. Hydroxypropyl-β-cyclo-dextrin (HP-β-CD) is used as an excipient in the itraconazole solution for oral dosing … Continued

Diagnostics and Devices: Accelerating Value Communication With Interactive Messaging

Learn how to accelerate decision-makers’ understanding of the value of diagnostic testing and medical devices to the health system. Two industry experts with over 35 years’ combined experience, Atlanta Kassatly, VP of Consulting at Certara, and Cynthia Doucet, President of OutcomeSynergy, discussed recent trends and issues that can hinder successful communication. Real-world solutions were reviewed … Continued

Exploring the Effect of COVID-19 on HTA Bodies Now and in the Future

The COVID-19 pandemic has turned our lives upside down and so many questions remain, including around how it is affecting health technology assessment (HTA) bodies. HTA bodies report that they have had to ramp up and are increasingly relying on smaller evidence sets. Going forward the priorities for and speed of assessments, particularly for vaccines, is likely to increase. On top of this, economies struggling with significantly increased levels of debt may respond by tightening budgets outside communicable diseases thus affecting assessment priorities, methods and recommendations.

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