A Scientific Perspective on Evaluation of Transporters in Drug Development

TL;DR

Understanding the role of transporters in drug development is crucial for optimizing dosing, minimizing adverse events, and improving therapeutic outcomes.

Transcript

hi my name is Leanne I'm senior advisor for regulatory programs and policy at the office of clinical pharmacology from Cedar FDA today I'm gonna present you in the next hour or so on scientific perspectives on evaluation of transporters in drug development we know that many factors can affect drug exposure and in turn its response this diagram show... Read More

Key Insights

• 🖐️ In addition to drug metabolizing enzymes, drug transporters also play a significant role in drug-drug interactions and variability in drug concentration and response.
• ❓ Transporters can affect drug absorption, distribution, metabolism, and excretion, as well as pharmacodynamic response.
• ❓ The evaluation of drug transporters is important in optimizing dosing and understanding drug interactions during drug development.
• 😒 The use of in vitro and in vivo models, as well as pharmacokinetic modeling, can help predict and understand the effects of drug transporters on drug exposure and response.
• 👨‍🔬 There is ongoing research and collaboration among regulatory agencies, industry, and academia to further understand and evaluate clinically relevant drug transporters.
• 💁 Transporter information is increasingly included in drug labeling to provide guidance on drug-drug interactions and optimal dosing.

Questions & Answers

Q: What are the key factors that can affect drug exposure and response?

Factors such as age, race, organ dysfunction, and drug-drug interactions can affect drug exposure and response.

Q: How do drug transporters affect drug absorption and distribution?

Drug transporters can control the movement of drugs across cell membranes, affecting their absorption and distribution in the body.

Q: What role do drug transporters play in drug interactions?

Drug transporters can interact with other drugs, affecting their concentration and potential for drug-drug interactions.

Q: Why is it important to evaluate drug transporters in drug development?

Understanding the role of drug transporters can help optimize dosing, minimize adverse events, and improve therapeutic outcomes for patients.

Summary & Key Takeaways

• Drug exposure and response can be affected by factors such as age, race, organ dysfunction, and drug interactions.

• Drug transporters can affect drug absorption, distribution, metabolism, and excretion, as well as pharmacodynamic response.

• Transporter evaluation is important in drug development to optimize dosing and understand drug interactions.