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1.
A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.
J Pharmacokinet Pharmacodyn
; 50(3): 147-172, 2023 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-36870005
2.
Phase 1b study of a small molecule antagonist of human chemokine (C-C motif) receptor 2 (PF-04136309) in combination with nab-paclitaxel/gemcitabine in first-line treatment of metastatic pancreatic ductal adenocarcinoma.
Invest New Drugs
; 38(3): 800-811, 2020 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-31297636
3.
A mechanistic pharmacokinetic model with drug and antidrug antibody interplay, and its application for assessing the impact of immunogenicity response on bioequivalence testing.
Br J Clin Pharmacol
; 86(11): 2182-2191, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-32285955
4.
PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.
Br J Cancer
; 120(2): 172-182, 2019 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-30568294
5.
A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis.
Br J Clin Pharmacol
; 82(1): 129-38, 2016 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-26909489
6.
Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab.
Br J Clin Pharmacol
; 82(6): 1568-1579, 2016 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-27530379
7.
A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01).
Br J Clin Pharmacol
; 78(6): 1281-90, 2014 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-25041377
8.
Oncology Combination Dose-Finding Study Design for Targeted and Immuno-Oncology Therapies.
Clin Pharmacol Ther
; 115(1): 29-35, 2024 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-37881828
9.
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework.
AAPS J
; 26(2): 31, 2024 03 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-38453809
10.
PK/PD model-informed dose selection for oncology phase I expansion: Case study based on PF-06939999, a PRMT5 inhibitor.
CPT Pharmacometrics Syst Pharmacol
; 12(11): 1619-1625, 2023 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-36394153
11.
Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development.
CPT Pharmacometrics Syst Pharmacol
; 2023 Nov 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-37969061
12.
Phase I study of oral irinotecan as a single-agent and given sequentially with capecitabine.
Invest New Drugs
; 30(1): 290-8, 2012 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-20857171
13.
Oncology dose optimization paradigms: knowledge gained and extrapolated from approved oncology therapeutics.
Cancer Chemother Pharmacol
; 90(3): 207-216, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35965268
14.
Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody-Drug Conjugates.
AAPS J
; 24(4): 73, 2022 06 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35688991
15.
Association between serum uric acid/HDL-cholesterol ratio and chronic kidney disease: a cross-sectional study based on a health check-up population.
BMJ Open
; 12(12): e066243, 2022 12 29.
Artículo
en Inglés
| MEDLINE | ID: mdl-36581406
16.
Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study.
Lancet Oncol
; 11(2): 129-35, 2010 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-20036194
17.
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs.
Cancer Chemother Pharmacol
; 87(1): 23-30, 2021 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-33237334
18.
Correction to: Population pharmacokinetics of PF05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2positive metastatic breast cancer.
Cancer Chemother Pharmacol
; 84(3): 667, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31292683
19.
Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis.
Expert Opin Biol Ther
; 19(10): 1065-1074, 2019 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-31284794
20.
Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer.
Cancer Chemother Pharmacol
; 84(1): 83-92, 2019 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-31053945