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1.
Targeting wild-type TP53 using AMG 232 in combination with MAPK inhibition in Metastatic Melanoma; a phase 1 study.
Invest New Drugs;
40(5): 1051-1065, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35635631
2.
Predicting Clinical Pharmacokinetics/Pharmacodynamics and Impact of Organ Impairment on siRNA-Based Therapeutics Using a Mechanistic Physiologically-Based Pharmacokinetic-Pharmacodynamic Model.
Clin Pharmacol Ther;
115(5): 1054-1064, 2024 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-38282246
3.
A Mechanistic Physiologically-Based Pharmacokinetic Platform Model to Guide Adult and Pediatric Intravenous and Subcutaneous Dosing for Bispecific T Cell Engagers.
Clin Pharmacol Ther;
115(3): 457-467, 2024 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-37746860
4.
Clinical Pharmacology Profile of AMG 119, the First Chimeric Antigen Receptor T (CAR-T) Cell Therapy Targeting Delta-Like Ligand 3 (DLL3), in Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC).
J Clin Pharmacol;
64(3): 362-370, 2024 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-37694295
5.
An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Clin Pharmacol Ther;
115(2): 188-200, 2024 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-37983584
6.
Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.
Clin Pharmacol Ther;
2024 Mar 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-38519861
7.
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper.
Clin Pharmacol Ther;
2024 May 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-38752712
8.
Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects.
Br J Clin Pharmacol;
76(6): 908-16, 2013 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-23488672
9.
Oncolytic viral kinetics mechanistic modeling of Talimogene Laherparepvec (T-VEC) a first-in-class oncolytic viral therapy in patients with advanced melanoma.
CPT Pharmacometrics Syst Pharmacol;
12(2): 250-260, 2023 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-36564918
10.
Mechanistic Pharmacokinetic/Pharmacodynamic Modeling in Support of a Patient-Convenient, Longer Dosing Interval for Carfilzomib, a Covalent Inhibitor of the Proteasome.
Clin Pharmacokinet;
62(5): 779-788, 2023 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-37072559
11.
Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.
Clin Pharmacol Ther;
114(3): 530-557, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37393588
12.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
AAPS J;
25(5): 78, 2023 07 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-37523051
13.
Recent advances and clinical pharmacology aspects of Chimeric Antigen Receptor (CAR) T-cellular therapy development.
Clin Transl Sci;
15(9): 2057-2074, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35677992
14.
Risk-Based Pharmacokinetic and Drug-Drug Interaction Characterization of Antibody-Drug Conjugates in Oncology Clinical Development: An International Consortium for Innovation and Quality in Pharmaceutical Development Perspective.
Clin Pharmacol Ther;
112(4): 754-769, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-34657311
15.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Mol Ther Methods Clin Dev;
26: 471-494, 2022 Sep 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-36092368
16.
Increased oxidative-modifications of cytosolic proteins in 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)-exposed rat liver.
Proteomics;
11(2): 202-11, 2011 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-21204248
17.
Effect of rifampicin on the pharmacokinetics and pharmacodynamics of saxagliptin, a dipeptidyl peptidase-4 inhibitor, in healthy subjects.
Br J Clin Pharmacol;
72(1): 92-102, 2011 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-21651615
18.
Panitumumab: A Review of Clinical Pharmacokinetic and Pharmacology Properties After Over a Decade of Experience in Patients with Solid Tumors.
Adv Ther;
38(7): 3712-3723, 2021 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-34152568
19.
The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer.
Cancer Chemother Pharmacol;
88(4): 665-672, 2021 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-34213592
20.
Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.
Clin Pharmacol Ther;
110(2): 297-310, 2021 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-33270249