Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends
| Autor: | Mitra Rocca, Qi Liu, Shiew-Mei Huang, Mitra Ahadpour |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Drug
media_common.quotation_subject precision medicine Pharmaceutical Science Clinical science Pharmacy 030226 pharmacology & pharmacy Models Biological law.invention Translational Research Biomedical 03 medical and health sciences 0302 clinical medicine Drug Development law Medicine Regulatory science Drug Approval media_common Clinical pharmacology business.industry United States Food and Drug Administration Precision medicine United States Drug development 030220 oncology & carcinogenesis Pharmacology Clinical Commentary regulatory science Engineering ethics clinical pharmacology Translational science business |
| Zdroj: | The AAPS Journal |
| ISSN: | 1550-7416 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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