Guide to When & Why to Evaluate ADME/DMPK & Drug-Drug Interactions Available

In Safety first: Assessing drugs early can preclude regulatory and health issues, a new ebook developed by a collaboration with some of our top scientists, we discuss how to create a thorough and well-executed drug development plan with proper risk assessment so you can be confident about the safety of your drug.

Overview

Every drug begins its journey to the clinic with preclinical testing to help predict whether the compound will work and if there is any risk to the patient. One required aspect of this risk assessment is to look for potential drug-drug interactions (DDI). This ebook will explore the regulatory expectations of drug developers to research DDI potential, the relationship between a drug’s characteristics and DDI risk, the methods available to test those characteristics, and considerations for drug developers to plan and successfully navigate DDI risk assessment.

Key Objectives:

• Understand the regulatory expectations for drug developers with respect to drug-drug interaction studies, particularly in the investigational new drug application process.
• Understand the relationship between a drug’s absorption, distribution, metabolism, and excretion (ADME) characteristics and the risk for drug-drug interactions.
• Learn about the methods available for testing drug characteristics that could impact the risk for drug-drug interactions.

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