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- Publisher
- Springer Journals
- Copyright
- Copyright © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2021
- eISSN
- 1550-7416
- DOI
- 10.1208/s12248-021-00563-3
- Publisher site
- See Article on Publisher Site
Abstract
In the regulatory setting, clinical pharmacology focuses on the impact of intrinsic and extrinsic factors on inter-patient and intra-subject variability in drug exposure and response. This translational science contributes to the understanding of the benefit-risk profile in individual patients and the development of relevant therapeutic monitoring and management strategies. Clinical pharmacology also plays a major role in the development and qualification of drug development tools. This article presented some recent examples to illustrate the important roles of clinical pharmacology in drug development and evaluation. In addition, emerging trends in clinical pharmacology regulatory sciences were also discussed, including the Model-Informed Drug Development (MIDD) pilot program, the use of real-world data to generate real-world evidence, and leveraging advances in basic, biomedical, and clinical science into useful tools for drug development and evaluation. Continued advances in clinical pharmacology can be the basis of more rational and efficient drug development and improved access to new drug treatments that are tailored to the patient to achieve better efficacy and safety.
Journal
"The AAPS Journal" – Springer Journals
Published: Apr 12, 2021