Detalles de la búsqueda
1.
First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects.
Br J Clin Pharmacol
; 86(4): 812-824, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-31758576
2.
Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study.
Br J Clin Pharmacol
; 84(8): 1776-1788, 2018 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-29672897
3.
Prediction of drug concentration-time profiles in children from adults: an allometric approach.
Am J Ther
; 22(2): 132-40, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-23676343
4.
Optimization of physicochemical properties and safety profile of novel bacterial topoisomerase type II inhibitors (NBTIs) with activity against Pseudomonas aeruginosa.
Bioorg Med Chem
; 22(19): 5392-409, 2014 Oct 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-25155913
5.
Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus.
CPT Pharmacometrics Syst Pharmacol
; 13(2): 281-295, 2024 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-38050332
6.
Model-Informed Selection of the Recommended Phase III Dose of the Inhibitor of Apoptosis Protein Inhibitor, Xevinapant, in Combination with Cisplatin and Concurrent Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Clin Pharmacol Ther
; 115(1): 52-61, 2024 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-37777832
7.
Asia-Inclusive Global Development of Enpatoran: Results of an Ethno-Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial.
Clin Pharmacol Ther
; 115(6): 1346-1357, 2024 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-38415785
8.
Safety, Tolerability, and Pharmacodynamics of the ADAMTS-5 Nanobody M6495: Two Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Studies in Healthy Subjects and Patients With Osteoarthritis.
ACR Open Rheumatol
; 6(4): 205-213, 2024 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-38311369
9.
Improvement of the pharmacokinetics and in vivo antibacterial efficacy of a novel type IIa topoisomerase inhibitor by formulation in liposomes.
Antimicrob Agents Chemother
; 57(10): 4816-24, 2013 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-23877679
10.
Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient-level placebo (Standard-of-Care) data to enable model-informed drug development.
CPT Pharmacometrics Syst Pharmacol
; 12(2): 180-195, 2023 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-36350330
11.
Opportunities and Challenges of Disease Progression Modeling in Drug Development - An IQ Perspective.
Clin Pharmacol Ther
; 114(2): 266-274, 2023 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-36802040
12.
Prediction of drug concentration-time data in humans from animals: a comparison of three methods.
Xenobiotica
; 42(8): 756-65, 2012 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-22360447
13.
Optimization of dose selection using multiple surrogates of toxicity as a continuous variable in phase I cancer trial.
Contemp Clin Trials
; 113: 106657, 2022 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-34954097
14.
Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need.
Clin Pharmacol Ther
; 112(2): 297-306, 2022 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-35390178
15.
Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations.
Cancer Chemother Pharmacol
; 90(1): 53-69, 2022 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-35771259
16.
To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias.
Clin Transl Sci
; 15(3): 601-609, 2022 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-34786861
17.
Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models.
CPT Pharmacometrics Syst Pharmacol
; 11(10): 1371-1381, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35852048
18.
Phase 1 study in healthy participants of the safety, pharmacokinetics, and pharmacodynamics of enpatoran (M5049), a dual antagonist of toll-like receptors 7 and 8.
Pharmacol Res Perspect
; 9(5): e00842, 2021 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-34414672
19.
Comparison of Various Phase I Combination Therapy Designs in Oncology for Evaluation of Early Tumor Shrinkage Using Simulations.
CPT Pharmacometrics Syst Pharmacol
; 9(12): 686-694, 2020 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-33080100
20.
Estimation of human drug clearance using multiexponential techniques.
J Clin Pharmacol
; 48(10): 1226-36, 2008 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-18559487