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Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends.
- Source :
-
The AAPS journal [AAPS J] 2021 Apr 12; Vol. 23 (3), pp. 54. Date of Electronic Publication: 2021 Apr 12. - Publication Year :
- 2021
-
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.
- Subjects :
- Drug Approval legislation & jurisprudence
Drug Development methods
Drug Development standards
Models, Biological
Pharmacology, Clinical methods
Pharmacology, Clinical standards
Translational Research, Biomedical standards
United States
United States Food and Drug Administration legislation & jurisprudence
United States Food and Drug Administration standards
Drug Development trends
Pharmacology, Clinical trends
Precision Medicine trends
Translational Research, Biomedical trends
Subjects
Details
- Language :
- English
- ISSN :
- 1550-7416
- Volume :
- 23
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- The AAPS journal
- Publication Type :
- Academic Journal
- Accession number :
- 33846878
- Full Text :
- https://doi.org/10.1208/s12248-021-00563-3