Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment: Role and Opportunities.
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| Title: | Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment: Role and Opportunities. |
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| Authors: | Ramamoorthy A; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA., Guinn D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA., Fletcher EP; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA., Pacanowski M; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA., Reynolds K; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA., Polli J; University of Maryland, Baltimore, MD, USA., Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA. |
| Source: | Journal of clinical pharmacology [J Clin Pharmacol] 2025 Sep; Vol. 65 (9), pp. 1176-1180. Date of Electronic Publication: 2025 Apr 16. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE; In Process |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1552-4604 |
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| DOI: | 10.1002/jcph.70029 |
