Detalles de la búsqueda
1.
Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria.
Clin Infect Dis
; 73(5): 903-906, 2021 09 07.
Artículo
Inglés
| MEDLINE | ID: mdl-33605994
2.
Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA.
Diabetologia
; 66(3): 603-604, 2023 03.
Artículo
Inglés
| MEDLINE | ID: mdl-36542112
3.
Reply to White et al.
Clin Infect Dis
; 75(2): 359, 2022 Aug 25.
Artículo
Inglés
| MEDLINE | ID: mdl-35023546
4.
Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.
J Pediatr Gastroenterol Nutr
; 65(3): 272-277, 2017 09.
Artículo
Inglés
| MEDLINE | ID: mdl-27875488
5.
Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling.
Drug Metab Dispos
; 44(7): 924-33, 2016 07.
Artículo
Inglés
| MEDLINE | ID: mdl-27079249
6.
Methods and strategies for assessing uncontrolled drug-drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group.
J Pharmacokinet Pharmacodyn
; 43(2): 123-35, 2016 Apr.
Artículo
Inglés
| MEDLINE | ID: mdl-26837775
7.
Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development: A Workshop Report.
Clin Pharmacol Ther
; 115(2): 201-205, 2024 02.
Artículo
Inglés
| MEDLINE | ID: mdl-37984065
8.
Application of Model-Informed Drug Development in Dose Selection and Optimization for siRNA Therapies.
J Clin Pharmacol
; 2024 Mar 01.
Artículo
Inglés
| MEDLINE | ID: mdl-38426370
9.
FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.
Clin Cancer Res
; 30(1): 17-22, 2024 01 05.
Artículo
Inglés
| MEDLINE | ID: mdl-37624619
10.
Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective.
J Clin Pharmacol
; 63 Suppl 2: S65-S77, 2023 11.
Artículo
Inglés
| MEDLINE | ID: mdl-37942906
11.
Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development Program.
J Clin Pharmacol
; 63(2): 259-265, 2023 02.
Artículo
Inglés
| MEDLINE | ID: mdl-36149807
12.
Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction.
Clin Pharmacol Ther
; 111(3): 624-634, 2022 03.
Artículo
Inglés
| MEDLINE | ID: mdl-34656075
13.
Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.
Clin Pharmacol Ther
; 111(3): 572-578, 2022 03.
Artículo
Inglés
| MEDLINE | ID: mdl-34807992
14.
FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes.
Clin Cancer Res
; 28(16): 3411-3416, 2022 08 15.
Artículo
Inglés
| MEDLINE | ID: mdl-35435961
15.
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.
CPT Pharmacometrics Syst Pharmacol
; 10(12): 1479-1484, 2021 12.
Artículo
Inglés
| MEDLINE | ID: mdl-34734497
16.
Anti-SARS-CoV-2 Repurposing Drug Database: Clinical Pharmacology Considerations.
CPT Pharmacometrics Syst Pharmacol
; 10(9): 973-982, 2021 09.
Artículo
Inglés
| MEDLINE | ID: mdl-34218521
17.
Model-Informed Drug Development in Pediatric Dose Selection.
J Clin Pharmacol
; 61 Suppl 1: S60-S69, 2021 06.
Artículo
Inglés
| MEDLINE | ID: mdl-34185906
18.
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.
AAPS J
; 23(3): 60, 2021 04 30.
Artículo
Inglés
| MEDLINE | ID: mdl-33931790
19.
A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies.
Clin Pharmacol Ther
; 108(1): 107-115, 2020 07.
Artículo
Inglés
| MEDLINE | ID: mdl-31957006
20.
Targeting 11q23 positive acute leukemia cells with high molecular weight-melanoma associated antigen-specific monoclonal antibodies.
Cancer Immunol Immunother
; 58(3): 415-27, 2009 Mar.
Artículo
Inglés
| MEDLINE | ID: mdl-18677475