Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends

• Published in: The AAPS journal Vol. 23; no. 3; p. 54
• Main Authors: Liu, Qi, Ahadpour, Mitra, Rocca, Mitra, Huang, Shiew-Mei
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 12.04.2021; Springer
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Commentary; Drug Approval - legislation & jurisprudence; Drug Development - methods; Drug Development - standards; Drug Development - trends; Drugs; Evidence-based medicine; Medical imaging equipment; Models, Biological; Pharmacology; Pharmacology, Clinical - methods; Pharmacology, Clinical - standards; Pharmacology, Clinical - trends; Pharmacology/Toxicology; Pharmacy; Precision Medicine - trends; Theme: Celebrating Women in the Pharmaceutical Sciences; Translational Research, Biomedical - standards; Translational Research, Biomedical - trends; United States; United States Food and Drug Administration - legislation & jurisprudence; United States Food and Drug Administration - standards; United States; drug development; clinical pharmacology; precision medicine; regulatory science
• ISSN: 1550-7416; 1550-7416
• DOI: 10.1208/s12248-021-00563-3

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.