Found: 26
Select item for more details and to access through your institution.
Development of a Generic Fetal Physiologically Based Pharmacokinetic Model and Prediction of Human Maternal and Fetal Organ Concentrations of Cefuroxime.
- Published in:
- Clinical Pharmacokinetics, 2024, v. 63, n. 1, p. 69, doi. 10.1007/s40262-023-01323-6
- By:
- Publication type:
- Article
Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015–2020.
- Published in:
- Journal of Clinical Pharmacology, 2023, v. 63, n. 3, p. 307, doi. 10.1002/jcph.2160
- By:
- Publication type:
- Article
Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure–Response.
- Published in:
- Journal of Clinical Pharmacology, 2023, v. 63, n. 1, p. 105, doi. 10.1002/jcph.2139
- By:
- Publication type:
- Article
Pediatric and Adult Placebo Response Rates in Placebo‐Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012–2020.
- Published in:
- Journal of Clinical Pharmacology, 2022, v. 62, n. 8, p. 970, doi. 10.1002/jcph.2035
- By:
- Publication type:
- Article
Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007 and 2020.
- Published in:
- Journal of Clinical Pharmacology, 2022, v. 62, n. 3, p. 397, doi. 10.1002/jcph.1973
- By:
- Publication type:
- Article
Pharmacological Arguments Against the Use of Ketamine in Nonmedical Settings.
- Published in:
- Journal of Clinical Pharmacology, 2022, v. 62, n. 1, p. 7, doi. 10.1002/jcph.1981
- By:
- Publication type:
- Article
Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration.
- Published in:
- Journal of Clinical Pharmacology, 2021, v. 61, p. S133, doi. 10.1002/jcph.1864
- By:
- Publication type:
- Article
Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir.
- Published in:
- Journal of Clinical Pharmacology, 2020, v. 60, n. 2, p. 240, doi. 10.1002/jcph.1515
- By:
- Publication type:
- Article
Ontogeny and the Application of Pharmacogenomics to Pediatric Drug Development.
- Published in:
- Journal of Clinical Pharmacology, 2019, v. 59, p. S82, doi. 10.1002/jcph.1488
- By:
- Publication type:
- Article
Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.
- Published in:
- Journal of Clinical Pharmacology, 2019, v. 59, n. 8, p. 1130, doi. 10.1002/jcph.1406
- By:
- Publication type:
- Article
Ontogeny and the Application of Pharmacogenomics to Pediatric Drug Development.
- Published in:
- Journal of Clinical Pharmacology, 2019, v. 59, p. S82, doi. 10.1002/jcph.1488
- By:
- Publication type:
- Article
Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.
- Published in:
- Journal of Clinical Pharmacology, 2018, v. 58, n. 7, p. 885, doi. 10.1002/jcph.1109
- By:
- Publication type:
- Article
Obesity and Pediatric Drug Development.
- Published in:
- Journal of Clinical Pharmacology, 2018, v. 58, n. 5, p. 650, doi. 10.1002/jcph.1054
- By:
- Publication type:
- Article
The personalized medicine revolution: Getting it right for children.
- Published in:
- Pediatric Transplantation, 2012, v. 16, n. 6, p. 530, doi. 10.1111/j.1399-3046.2011.01638.x
- By:
- Publication type:
- Article
Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling.
- Published in:
- Clinical Pharmacokinetics, 2020, v. 59, n. 11, p. 1433, doi. 10.1007/s40262-020-00897-9
- By:
- Publication type:
- Article
Application of Quantitative Systems Pharmacology to Pediatric Drug Safety Assessment.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 114, n. 4, p. 748, doi. 10.1002/cpt.2990
- By:
- Publication type:
- Article
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 3, p. 528, doi. 10.1002/cpt.2822
- By:
- Publication type:
- Article
Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals.
- Published in:
- Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 4, p. 997, doi. 10.1002/cpt.2306
- By:
- Publication type:
- Article
Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 5, p. 1018, doi. 10.1002/cpt.1886
- By:
- Publication type:
- Article
Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 4, p. 710, doi. 10.1002/cpt.1849
- By:
- Publication type:
- Article
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 3, p. 555, doi. 10.1002/cpt.1117
- By:
- Publication type:
- Article
Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 5, p. 983, doi. 10.1002/cpt.971
- By:
- Publication type:
- Article
Pediatric Drug Development: Outlook for Science‐Based Innovation.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 3, p. 376, doi. 10.1002/cpt.1001
- By:
- Publication type:
- Article
Adolescent Dosing and Labeling Since the Food and Drug Administration Amendments Act of 2007.
- Published in:
- JAMA Pediatrics, 2013, v. 167, n. 10, p. 926, doi. 10.1001/jamapediatrics.2013.465
- By:
- Publication type:
- Article
Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.
- Published in:
- Journal of Clinical Pharmacology, 2016, v. 56, n. 11, p. 1326, doi. 10.1002/jcph.744
- By:
- Publication type:
- Article
Drug Development for Pediatric Neurogenic Bladder Dysfunction: Dosing, Endpoints, and Study Design.
- Published in:
- Journal of Clinical Pharmacology, 2014, v. 54, n. 11, p. 1239, doi. 10.1002/jcph.345
- By:
- Publication type:
- Article