Works matching IS 00099236 AND DT 2019 AND VI 105 AND IP 4
Results: 40
Highlights.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 782, doi. 10.1002/cpt.1388
- Publication type:
- Article
In This Issue.
- Published in:
- 2019
- Publication type:
- Table of Contents
ASCPT News.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 784, doi. 10.1002/cpt.1386
- Publication type:
- Article
Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 778, doi. 10.1002/cpt.1367
- By:
- Publication type:
- Article
Experiences With and Challenges Afforded by Expedited Regulatory Pathways.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 795, doi. 10.1002/cpt.1365
- By:
- Publication type:
- Article
Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 878, doi. 10.1002/cpt.1364
- By:
- Publication type:
- Article
Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 899, doi. 10.1002/cpt.1363
- By:
- Publication type:
- Article
The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 829, doi. 10.1002/cpt.1362
- By:
- Publication type:
- Article
Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 886, doi. 10.1002/cpt.1354
- By:
- Publication type:
- Article
Evaluating the Use of Nonrandomized Real‐World Data Analyses for Regulatory Decision Making.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 867, doi. 10.1002/cpt.1351
- By:
- Publication type:
- Article
Can Innovation in Regulatory Science Address Health Care Cost Burdens?
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 809, doi. 10.1002/cpt.1334
- By:
- Publication type:
- Article
Model‐Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First‐Line Anaplastic Lymphoma Kinase + Non‐Small Cell Lung Cancer.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 826, doi. 10.1002/cpt.1340
- By:
- Publication type:
- Article
The US Food and Drug Administration Centers for Regulatory Science and Innovation: Current Activities and Future Promise to Accelerate Innovations.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 792, doi. 10.1002/cpt.1339
- By:
- Publication type:
- Article
European Medicines Agency‐Health Technology Assessment Parallel Consultation Platform: An Industry Perspective.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 822, doi. 10.1002/cpt.1337
- By:
- Publication type:
- Article
Multistakeholder Advice at the European Medicines Agency: Is It Still Needed?
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 819, doi. 10.1002/cpt.1335
- By:
- Publication type:
- Article
Efficacy and Effectiveness Too Trials: Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 857, doi. 10.1002/cpt.1347
- By:
- Publication type:
- Article
"Asian" Phenotype Underestimates the Genetic Diversity of Asia yet Overstates its Impact on Variability in Drug Disposition and Pharmacodynamics.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 802, doi. 10.1002/cpt.1329
- By:
- Publication type:
- Article
Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 943, doi. 10.1002/cpt.1303
- By:
- Publication type:
- Article
The Confluence of Accelerated Regulatory and Health Technology Assessment Access Pathways.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 935, doi. 10.1002/cpt.1315
- By:
- Publication type:
- Article
Defining Treatment Effects: A Primer for Nonstatisticians.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 932, doi. 10.1002/cpt.1313
- By:
- Publication type:
- Article
Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 962, doi. 10.1002/cpt.1310
- By:
- Publication type:
- Article
Research Projects Supported by the University of California, San Francisco‐Stanford Center of Excellence in Regulatory Science and Innovation.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 815, doi. 10.1002/cpt.1308
- By:
- Publication type:
- Article
Recognizing that Evidence is Made, not Born.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 844, doi. 10.1002/cpt.1317
- By:
- Publication type:
- Article
Recent US Food and Drug Administration Efforts to Integrate the Patient's Perspective in Drug Development and Decision Making.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 789, doi. 10.1002/cpt.1290
- By:
- Publication type:
- Article
International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 926, doi. 10.1002/cpt.1289
- By:
- Publication type:
- Article
Hemodynamic Effects of Intravenous, High‐Dose Lipid Emulsion With and Without Metoprolol Infusion in Healthy Volunteers: A Randomized Clinical Trial.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 1009, doi. 10.1002/cpt.1281
- By:
- Publication type:
- Article
M281, an Anti‐FcRn Antibody: Pharmacodynamics, Pharmacokinetics, and Safety Across the Full Range of IgG Reduction in a First‐in‐Human Study.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 1031, doi. 10.1002/cpt.1276
- By:
- Publication type:
- Article
A Model‐Based Approach to Quantify the Time‐Course of Anti‐Drug Antibodies for Therapeutic Proteins.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 970, doi. 10.1002/cpt.1267
- By:
- Publication type:
- Article
Impact of Acute Alcohol Exposure on P‐Glycoprotein Function at the Blood‐Brain Barrier Assessed Using <sup>11</sup>C‐Metoclopramide PET Imaging.
- Published in:
- 2019
- By:
- Publication type:
- Letter to the Editor
Response to "Impact of Acute Alcohol Exposure on P‐Glycoprotein Function at the Blood–Brain Barrier Assessed Using <sup>11</sup>C‐Metoclopramide PET Imaging".
- Published in:
- 2019
- By:
- Publication type:
- Letter to the Editor
Pharmacokinetics and Transplacental Transfer of Fluoxetine Enantiomers and Their Metabolites in Pregnant Women.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 1003, doi. 10.1002/cpt.1263
- By:
- Publication type:
- Article
Impact of Brexit on UK and EU Drug Regulation and Patient Access.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 923, doi. 10.1002/cpt.1261
- By:
- Publication type:
- Article
The Genotype for DPYD Risk Variants in Patients With Colorectal Cancer and the Related Toxicity Management Costs in Clinical Practice.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 994, doi. 10.1002/cpt.1257
- By:
- Publication type:
- Article
Claims Data Studies of Direct Oral Anticoagulants Can Achieve Balance in Important Clinical Parameters Only Observable in Electronic Health Records.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 979, doi. 10.1002/cpt.1256
- By:
- Publication type:
- Article
Innovation in Pharmacovigilance: Use of Artificial Intelligence in Adverse Event Case Processing.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 954, doi. 10.1002/cpt.1255
- By:
- Publication type:
- Article
Global Challenges in Regulatory Capacity and Capability Building: Extrapolating Lessons Learned From the HSA.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 805, doi. 10.1002/cpt.1253
- By:
- Publication type:
- Article
Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 798, doi. 10.1002/cpt.1237
- By:
- Publication type:
- Article
Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 912, doi. 10.1002/cpt.1226
- By:
- Publication type:
- Article
Issue Information.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 769, doi. 10.1002/cpt.1153
- Publication type:
- Article
Application of Physiologically Based Pharmacokinetic Modeling to Predict Pharmacokinetics in Healthy Japanese Subjects.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 1018, doi. 10.1002/cpt.1240
- By:
- Publication type:
- Article