Zdrowie i gospodarka · 22/05/2018

Framework for Assessing pH-Dependent Drug-Drug Interactions; Establishment of a Public Docket; Request for Comments

The Food and Drug Administration (FDA) is establishing a public docket to assist with the development of a policy or guidance document on the assessment of pH-dependent drug-drug interactions (DDIs). In October 2017, FDA published two draft guidance documents on DDIs entitled "In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies" (In Vitro Studies Draft Guidance) and "Clinical Drug Interaction Studies--Study Design, Data Analysis, and Clinical Implications" (Clinical Drug Interaction Studies Draft Guidance). These two draft guidances focus on enzyme- and transporter-based DDIs and do not include a framework to assess pH-dependent DDIs. FDA is seeking public input on best practices in the planning and evaluation of pH-dependent DDIs.