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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.
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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  Data: <searchLink fieldCode="AU" term="%22Ramamoorthy+A%22">Ramamoorthy A</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Guinn+D%22">Guinn D</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Fletcher+EP%22">Fletcher EP</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Pacanowski+M%22">Pacanowski M</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Reynolds+K%22">Reynolds K</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Polli+J%22">Polli J</searchLink>; University of Maryland, Baltimore, MD, USA.<br /><searchLink fieldCode="AU" term="%22Madabushi+R%22">Madabushi R</searchLink>; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
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  Data: <searchLink fieldCode="JN" term="%220366372%22">Journal of clinical pharmacology</searchLink> [J Clin Pharmacol] 2025 Sep; Vol. 65 (9), pp. 1176-1180. <i>Date of Electronic Publication: </i>2025 Apr 16.
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        Value: 10.1002/jcph.70029
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