Found: 45
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Closing the gap: A United States perspective on enhancing drug evaluation in older adults.
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- Journal of the American Geriatrics Society, 2024, v. 72, n. 9, p. 2903, doi. 10.1111/jgs.18903
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- Article
Heterogeneity in treatment effects across diverse populations.
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- Pharmaceutical Statistics, 2021, v. 20, n. 5, p. 929, doi. 10.1002/pst.2161
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- Article
Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.
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- Pharmaceutical Research, 2022, v. 39, n. 8, p. 1669, doi. 10.1007/s11095-022-03288-w
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- Article
Hyperforin in St. John’s wort drug interactions.
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- European Journal of Clinical Pharmacology, 2006, v. 62, n. 3, p. 225, doi. 10.1007/s00228-006-0096-0
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- Article
Once-daily tobramycin in cystic fibrosis: better for clinical outcome than thrice-daily tobramycin but more resistance development?
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- Journal of Antimicrobial Chemotherapy (JAC), 2006, v. 58, n. 4, p. 822, doi. 10.1093/jac/dkl328
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- Article
Sorafenib for the Treatment of Unresectable Hepatocellular Carcinoma.
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- Oncologist, 2009, v. 14, n. 1, p. 95, doi. 10.1634/theoncologist.2008-0185
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- Article
Statin Drug‐Drug Interactions: Pharmacokinetic Basis of FDA Labeling Recommendations and Comparison Across Common Tertiary Clinical Resources.
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- Journal of Clinical Pharmacology, 2024, v. 64, n. 6, p. 704, doi. 10.1002/jcph.2406
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- Article
Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities.
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- Journal of Clinical Pharmacology, 2023, v. 63, p. S10, doi. 10.1002/jcph.2327
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- Article
Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods.
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- Journal of Clinical Pharmacology, 2023, v. 63, n. 7, p. 755, doi. 10.1002/jcph.2229
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- Article
Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.
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- Journal of Clinical Pharmacology, 2023, v. 63, p. S106, doi. 10.1002/jcph.2242
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- Article
US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information.
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- Journal of Clinical Pharmacology, 2023, v. 63, n. 6, p. 695, doi. 10.1002/jcph.2208
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- Article
Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective.
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- Journal of Clinical Pharmacology, 2023, v. 63, n. 3, p. 273, doi. 10.1002/jcph.2177
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- Article
Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2014, v. 41, n. 6, p. 693, doi. 10.1007/s10928-014-9394-9
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- Article
Misclassification and discordance of measured blood pressure from patient's true blood pressure in current clinical practice: a clinical trial simulation case study.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2012, v. 39, n. 3, p. 283, doi. 10.1007/s10928-012-9250-8
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- Article
Need for Representation of Pediatric Patients with Obesity in Clinical Trials.
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- Children, 2023, v. 10, n. 10, p. 1640, doi. 10.3390/children10101640
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- Article
Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation.
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- AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00804-7
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- Article
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.
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- AAPS Journal, 2021, v. 23, n. 3, p. 1, doi. 10.1208/s12248-021-00585-x
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- Article
Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020.
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- CTS: Clinical & Translational Science, 2023, v. 16, n. 10, p. 2046, doi. 10.1111/cts.13611
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- Article
Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA.
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- CTS: Clinical & Translational Science, 2022, v. 15, n. 11, p. 2583, doi. 10.1111/cts.13362
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- Article
The US Food and Drug Administration's Model‐Informed Drug Development Meeting Program: From Pilot to Pathway.
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- Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 2, p. 278, doi. 10.1002/cpt.3228
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- Article
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins.
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- Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 3, p. 440, doi. 10.1002/cpt.3178
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- Article
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.
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- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 3, p. 528, doi. 10.1002/cpt.2822
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- Article
Current Perspective on Residual Knowledge Gaps in the Assessment of Transporter‐Mediated Drug Interactions.
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- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 3, p. 450, doi. 10.1002/cpt.2671
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- Article
Roadmap to 2030 for Drug Evaluation in Older Adults.
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- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 2, p. 210, doi. 10.1002/cpt.2452
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- Article
Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
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- Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 2, p. 285, doi. 10.1002/cpt.2151
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- Article
Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 3, p. 697, doi. 10.1002/cpt.2038
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- Article
A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 1, p. 123, doi. 10.1002/cpt.2068
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- Article
Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 1, p. 25, doi. 10.1002/cpt.1933
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- Article
Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug‐Drug Interaction Risks.
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- Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 1, p. 42, doi. 10.1002/cpt.1984
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- Article
Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use.
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- Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 4, p. 710, doi. 10.1002/cpt.1849
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- Article
Model‐Informed Drug Development: A Regulatory Perspective on Progress.
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- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 91, doi. 10.1002/cpt.1475
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- Article
The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact.
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- Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 74, doi. 10.1002/cpt.1457
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- Article
Considerations for Biologic Product Drug–Drug Interactions: A Regulatory Perspective.
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- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 6, p. 1332, doi. 10.1002/cpt.1366
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- Article
Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations.
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- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 899, doi. 10.1002/cpt.1363
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- Article
Transporters in Drug Development: Scientific and Regulatory Considerations.
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- Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 5, p. 793, doi. 10.1002/cpt.1214
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- Article
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.
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- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 12, p. 1479, doi. 10.1002/psp4.12709
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- Article
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary.
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- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 11, p. 1271, doi. 10.1002/psp4.12706
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- Article
Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives.
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- CPT: Pharmacometrics & Systems Pharmacology, 2019, v. 8, n. 2, p. 87, doi. 10.1002/psp4.12372
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- Article
A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development.
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- CPT: Pharmacometrics & Systems Pharmacology, 2019, v. 8, n. 1, p. 9, doi. 10.1002/psp4.12379
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- Article
Clopidogrel, CYP2C19 and proton pump inhibitors: What we know and what it means.
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- Journal of Clinical Pharmacology, 2014, v. 54, n. 8, p. 884, doi. 10.1002/jcph.337
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- Article
Dosing Rationale for Liraglutide in Type 2 Diabetes Mellitus: A Pharmacometric Assessment.
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- Journal of Clinical Pharmacology, 2012, v. 52, n. 12, p. 1815, doi. 10.1177/0091270011430504
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- Article
Clinical Pharmacology Basis of Deriving Dosing Recommendations for Dabigatran in Patients With Severe Renal Impairment.
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- Journal of Clinical Pharmacology, 2012, v. 52, p. 119S, doi. 10.1177/0091270011415527
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- Article
Pharmacokinetic and Pharmacodynamic Basis for Effective Argatroban Dosing in Pediatrics.
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- Journal of Clinical Pharmacology, 2011, v. 51, n. 1, p. 19, doi. 10.1177/0091270010365550
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- Article
Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs.
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- CTS: Clinical & Translational Science, 2019, v. 12, n. 3, p. 236, doi. 10.1111/cts.12626
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- Article
Emerging Role of Organ‐on‐a‐Chip Technologies in Quantitative Clinical Pharmacology Evaluation.
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- CTS: Clinical & Translational Science, 2019, v. 12, n. 2, p. 113, doi. 10.1111/cts.12627
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- Article