Targeted Medicines: Enhancing Efficacy, Safety, And Regulatory Success

By Elisabeth Rouits, PharmD, PhD, Global Head Clinical Pharmacology-Pharmacometrics

This article discusses the importance of pharmacological considerations in the development and marketing of targeted medicines. It highlights the need for expertise in various fields such as research and development, statistics, market access, patient safety, regulatory affairs, and quality management. It emphasizes the growing trend of targeted therapies in the pharmaceutical industry and the need for companies to stay updated with evolving technologies and industry insights.

The article emphasizes the importance of a comprehensive pharmacological approach in developing targeted medicines. It also discusses the need to consider individual patient characteristics, metabolic capacities, and genetic influences to optimize drug dosing and administration. By customizing treatment regimens, organizations can maximize efficacy, minimize side effects, enhance treatment response, adapt to patient needs over time, and meet regulatory requirements more effectively. The article also highlights the importance of generating comprehensive pharmacokinetic and pharmacodynamic data to support dosing regimens and the value of translational medicine and dosing-optimization efforts.