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Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharmacology.
- Published in:
- Journal of Clinical Pharmacology, 2020, v. 60, p. S160, doi. 10.1002/jcph.1767
- By:
- Publication type:
- Article
Dosing Recommendations for Pediatric Patients With Renal Impairment.
- Published in:
- Journal of Clinical Pharmacology, 2020, v. 60, n. 12, p. 1551, doi. 10.1002/jcph.1676
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- Publication type:
- Article
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharmacology.
- Published in:
- Journal of Clinical Pharmacology, 2020, v. 60, p. S160, doi. 10.1002/jcph.1767
- By:
- Publication type:
- Article
Incorporating Ontogeny in Physiologically Based Pharmacokinetic Modeling to Improve Pediatric Drug Development: What We Know About Developmental Changes in Membrane Transporters.
- Published in:
- Journal of Clinical Pharmacology, 2019, v. 59, p. S56, doi. 10.1002/jcph.1489
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- Publication type:
- Article
Incorporating Ontogeny in Physiologically Based Pharmacokinetic Modeling to Improve Pediatric Drug Development: What We Know About Developmental Changes in Membrane Transporters.
- Published in:
- Journal of Clinical Pharmacology, 2019, v. 59, p. S56, doi. 10.1002/jcph.1489
- By:
- Publication type:
- Article
Regulatory Perspectives on Designing Pharmacokinetic Studies and Optimizing Labeling Recommendations for Patients With Chronic Kidney Disease.
- Published in:
- Journal of Clinical Pharmacology, 2012, v. 52, p. 79S, doi. 10.1177/0091270011415410
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- Publication type:
- Article
Evaluation of Exposure Change of Nonrenally Eliminated Drugs in Patients With Chronic Kidney Disease Using Physiologically Based Pharmacokinetic Modeling and Simulation.
- Published in:
- Journal of Clinical Pharmacology, 2012, v. 52, p. 91S, doi. 10.1177/0091270011415528
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- Publication type:
- Article
Clinical Pharmacology Studies in Patients with Renal Impairment: Past Experience and Regulatory Perspectives.
- Published in:
- Journal of Clinical Pharmacology, 2000, v. 40, n. 1, p. 31, doi. 10.1177/009127000004000103
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- Publication type:
- Article
Predicting Nonlinear Pharmacokinetics of Omeprazole Enantiomers and Racemic Drug Using Physiologically Based Pharmacokinetic Modeling and Simulation: Application to Predict Drug/Genetic Interactions.
- Published in:
- Pharmaceutical Research, 2014, v. 31, n. 8, p. 1919, doi. 10.1007/s11095-013-1293-z
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- Publication type:
- Article
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends.
- Published in:
- AAPS Journal, 2021, v. 23, n. 3, p. 1, doi. 10.1208/s12248-021-00563-3
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- Publication type:
- Article
Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors.
- Published in:
- AAPS Journal, 2020, v. 22, n. 2, p. 1, doi. 10.1208/s12248-020-0433-8
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- Publication type:
- Article
AAPS Workshop Report: Strategies to Address Therapeutic Protein-Drug Interactions during Clinical Development.
- Published in:
- 2011
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- Publication type:
- Report
Predicting Drug–Drug Interactions: An FDA Perspective.
- Published in:
- AAPS Journal, 2009, v. 11, n. 2, p. 300, doi. 10.1208/s12248-009-9106-3
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- Publication type:
- Article
Emerging Role of Organ‐on‐a‐Chip Technologies in Quantitative Clinical Pharmacology Evaluation.
- Published in:
- CTS: Clinical & Translational Science, 2019, v. 12, n. 2, p. 113, doi. 10.1111/cts.12627
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- Publication type:
- Article
Role of CYP3A in Oral Contraceptives Clearance.
- Published in:
- CTS: Clinical & Translational Science, 2018, v. 11, n. 3, p. 251, doi. 10.1111/cts.12499
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- Publication type:
- Article
A sensitive high performance liquid chromatography microassay for bemoradan, a novel cardiotonic agent, in plasma/serum using a semi-automatic liquid/solid extraction sample preparation system-AASP®.
- Published in:
- Biomedical Chromatography, 1990, v. 4, n. 2, p. 52, doi. 10.1002/bmc.1130040203
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- Publication type:
- Article
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.
- Published in:
- AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00819-0
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- Publication type:
- Article
Assessment of the Quality and Quantity of Drug-Drug Interaction Studies in Recent NDA Submissions: Study Design and Data Analysis Issues.
- Published in:
- Journal of Clinical Pharmacology, 1999, v. 39, n. 10, p. 1006, doi. 10.1177/009127009903901002
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- Publication type:
- Article
FDA Evaluations Using In Vitro Metabolism to Predict and Interpret In Vivo Metabolic Drug-Drug Interactions: Impact on Labeling.
- Published in:
- Journal of Clinical Pharmacology, 1999, v. 39, n. 9, p. 899, doi. 10.1177/009127009903900902
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- Publication type:
- Article
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 9, p. 973, doi. 10.1002/psp4.12681
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- Publication type:
- Article
A Novel Physiologically Based Model of Creatinine Renal Disposition to Integrate Current Knowledge of Systems Parameters and Clinical Observations.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2020, v. 9, n. 6, p. 310, doi. 10.1002/psp4.12509
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- Publication type:
- Article
Mechanistic Models as Framework for Understanding Biomarker Disposition: Prediction of Creatinine‐Drug Interactions.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2020, v. 9, n. 5, p. 282, doi. 10.1002/psp4.12508
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- Publication type:
- Article
Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2020, v. 9, n. 1, p. 21, doi. 10.1002/psp4.12479
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- Publication type:
- Article
Metformin Disrupts Bile Acid Efflux by Repressing Bile Salt Export Pump Expression.
- Published in:
- Pharmaceutical Research, 2020, v. 37, n. 2, p. 1, doi. 10.1007/s11095-019-2753-x
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- Publication type:
- Article
Connecting Hydroxychloroquine In Vitro Antiviral Activity to In Vivo Concentration for Prediction of Antiviral Effect: A Critical Step in Treating Patients With Coronavirus Disease 2019.
- Published in:
- Clinical Infectious Diseases, 2020, v. 71, n. 12, p. 3232, doi. 10.1093/cid/ciaa623
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- Publication type:
- Article
In Memoriam Arthur J. Atkinson, Jr. (1938–2024).
- Published in:
- Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 1, p. 20, doi. 10.1002/cpt.3300
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- Publication type:
- Article
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization.
- Published in:
- Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 4, p. 890, doi. 10.1002/cpt.3191
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- Publication type:
- Article
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins.
- Published in:
- Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 3, p. 440, doi. 10.1002/cpt.3178
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- Publication type:
- Article
Pharmacokinetics‐Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap.
- Published in:
- Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 3, p. 404, doi. 10.1002/cpt.3145
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- Publication type:
- Article
The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non‐Small Cell Lung Cancer Treated With a PD‐1/PD‐L1 Blocking Antibody Using Real‐World and Trial Data.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 5, p. 1139, doi. 10.1002/cpt.2874
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- Publication type:
- Article
Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 4, p. 771, doi. 10.1002/cpt.2668
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- Publication type:
- Article
Model‐Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 62, doi. 10.1002/cpt.2722
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- Publication type:
- Article
More Than Pharmacokinetics: Transporters in Clinical Pharmacology.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 3, p. 423, doi. 10.1002/cpt.2710
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- Publication type:
- Article
Current Perspective on Residual Knowledge Gaps in the Assessment of Transporter‐Mediated Drug Interactions.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 3, p. 450, doi. 10.1002/cpt.2671
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- Publication type:
- Article
Roadmap to 2030 for Drug Evaluation in Older Adults.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 2, p. 210, doi. 10.1002/cpt.2452
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- Publication type:
- Article
Toward Bridging Unmet Medical Need in Early Alzheimer's Disease: An Evaluation of Beta‐Amyloid (Aβ) Plaque Burden as a Potential Drug Development Tool.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 4, p. 728, doi. 10.1002/cpt.2536
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- Publication type:
- Article
Cannabis for Medical Use: Clinical Pharmacology Perspectives on Scientific and Regulatory Challenges.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 4, p. 732, doi. 10.1002/cpt.2470
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- Publication type:
- Article
Do Inhibitory Metabolites Impact DDI Risk Assessment? Analysis of in vitro and in vivo Data from NDA Reviews Between 2013 and 2018.
- Published in:
- Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 2, p. 452, doi. 10.1002/cpt.2259
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- Publication type:
- Article
Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
- Published in:
- Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 2, p. 285, doi. 10.1002/cpt.2151
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- Publication type:
- Article
Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019.
- Published in:
- JAMA Network Open, 2022, v. 5, n. 10, p. e2236149, doi. 10.1001/jamanetworkopen.2022.36149
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- Publication type:
- Article
Optimizing drug development: strategies to assess drug metabolism/transporter interaction potential—towards a consensus.
- Published in:
- British Journal of Clinical Pharmacology, 2001, v. 52, n. 1, p. 107, doi. 10.1046/j.0306-5251.2001.Temp.1441.x
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- Publication type:
- Article
Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.
- Published in:
- Biopharmaceutics & Drug Disposition, 2012, v. 33, n. 2, p. 99, doi. 10.1002/bdd.1771
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- Publication type:
- Article
PBPK as a tool in regulatory review.
- Published in:
- Biopharmaceutics & Drug Disposition, 2012, v. 33, n. 2, p. 51, doi. 10.1002/bdd.1777
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- Publication type:
- Article
A pharmacokinetic evaluation of HIV protease inhibitors, cyclic ureas, in rats and dogs.
- Published in:
- Biopharmaceutics & Drug Disposition, 1994, v. 15, n. 7, p. 535, doi. 10.1002/bdd.2510150702
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- Publication type:
- Article
Simultaneous monitoring of bemoradan pharmacokinetics and hemodynamics in mongrel dogs.
- Published in:
- Biopharmaceutics & Drug Disposition, 1992, v. 13, n. 7, p. 539, doi. 10.1002/bdd.2510130707
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- Publication type:
- Article
Clinical pharmacokinetics of etintidine.
- Published in:
- Biopharmaceutics & Drug Disposition, 1988, v. 9, n. 5, p. 477, doi. 10.1002/bod.2510090506
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- Publication type:
- Article
Pharmacokinetics and bioavailability of etintidine in beagle dogs: Effects of routes of administration, doses, dosage forms, and chronic dosing.
- Published in:
- Biopharmaceutics & Drug Disposition, 1988, v. 9, n. 1, p. 71, doi. 10.1002/bod.2510090108
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- Publication type:
- Article
Etintidine-theophylline interaction study in humans.
- Published in:
- Biopharmaceutics & Drug Disposition, 1987, v. 8, n. 6, p. 561, doi. 10.1002/bdd.2510080607
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- Publication type:
- Article
Pharmacokinetics of drugs in blood I. Unusual distribution of gentamicin.
- Published in:
- Biopharmaceutics & Drug Disposition, 1981, v. 2, n. 1, p. 89, doi. 10.1002/bdd.2510020110
- By:
- Publication type:
- Article
Clinical pharmacology as a cornerstone of orphan drug development.
- Published in:
- 2011
- By:
- Publication type:
- journal article