Works by Yin, Donghua

Results: 30

A phase I and pharmacokinetic study of a powder-filled capsule formulation of oral irinotecan (CPT-11) given daily for 5 days every 3 weeks in patients with advanced solid tumors.

Published in:

2006

By:

Pitot, Henry C.;
Adjei, Alex A.;
Reid, Joel M.;
Sloan, Jeff A.;
Atherton, Pamela J.;
Rubin, Joseph;
Alberts, Steven R.;
Duncan, Barbara A.;
Denis, Louis;
Schaaf, Larry J.;
Donghua Yin;
Sharma, Amarnath;
McGovren, Patrick;
Miller, Langdon L.;
Erlichman, Charles;
Yin, Donghua

Publication type:

journal article

PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study.

Published in:

2019

By:

Pegram, Mark D.;
Bondarenko, Igor;
Zorzetto, Marina Moreira Costa;
Hingmire, Sachin;
Iwase, Hirotaka;
Krivorotko, Petr V.;
Lee, Keun Seok;
Li, Rubi K.;
Pikiel, Joanna;
Aggarwal, Rajesh;
Ewesuedo, Reginald;
Freyman, Amy;
Li, Ray;
Vana, Alicia;
Yin, Donghua;
Zacharchuk, Charles;
Tan-Chiu, Elizabeth

Publication type:

journal article

Oncology Combination Dose‐Finding Study Design for Targeted and Immuno‐Oncology Therapies.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 1, p. 29, doi. 10.1002/cpt.3085

By:

Zhou, Li;
Reddy, Micaela B.;
Mittapalli, Rajendar K.;
Yang, Jing;
Yin, Donghua

Publication type:

Article

Landscape analysis of adverse events and dose intensity for FDA approved oncology small molecules.

Published in:

Cancer Chemotherapy & Pharmacology, 2025, v. 95, n. 1, p. 1, doi. 10.1007/s00280-024-04721-0

By:

Collins, Keagan P.;
Yin, Donghua;
Pithavala, Yazdi K.;
Mittapalli, Rajendar K.

Publication type:

Article

Oncology dose optimization paradigms: knowledge gained and extrapolated from approved oncology therapeutics.

Published in:

2022

By:

Mittapalli, Rajendar K.;
Guo, Cen;
Drescher, Stefanie K.;
Yin, Donghua

Publication type:

journal article

Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs.

Published in:

Cancer Chemotherapy & Pharmacology, 2021, v. 87, n. 1, p. 23, doi. 10.1007/s00280-020-04202-0

By:

Mittapalli, Rajendar K.;
Yin, Donghua;
Beaupre, Darrin;
Palaparthy, Rameshraja

Publication type:

Article

Correction to: Population pharmacokinetics of PF‑05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin<sup>®</sup>) in patients with HER2‑positive metastatic breast cancer.

Published in:

2019

By:

Chen, Xiaoying;
Li, Cheryl;
Ewesuedo, Reginald;
Yin, Donghua

Publication type:

corrected article

Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin<sup>®</sup>) in patients with HER2-positive metastatic breast cancer.

Published in:

2019

By:

Chen, Xiaoying;
Li, Cheryl;
Ewesuedo, Reginald;
Yin, Donghua

Publication type:

journal article

Figitumumab in patients with refractory metastatic colorectal cancer previously treated with standard therapies: a nonrandomized, open-label, phase II trial.

Published in:

Cancer Chemotherapy & Pharmacology, 2014, v. 73, n. 4, p. 695, doi. 10.1007/s00280-014-2391-2

By:

Becerra, Carlos;
Salazar, Ramon;
Garcia-Carbonero, Rocio;
Thomas, Anne;
Vázquez-Mazón, Federico;
Cassidy, James;
Maughan, Tim;
Castillo, Manuel;
Iveson, Tim;
Yin, Donghua;
Green, Stephanie;
Bergsland, Emily

Publication type:

Article

Safety, tolerability, and pharmacokinetics of the anti-IGF-1R monoclonal antibody figitumumab in patients with refractory adrenocortical carcinoma.

Published in:

Cancer Chemotherapy & Pharmacology, 2010, v. 65, n. 4, p. 765, doi. 10.1007/s00280-009-1083-9

By:

Haluska, Paul;
Worden, Frank;
Olmos, David;
Donghua Yin;
Schteingart, David;
Batzel, Gretchen N.;
Paccagnella, M. Luisa;
de Bono, Johann S.;
Gualberto, Antonio;
Hammer, Gary D.

Publication type:

Article

A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2023, v. 50, n. 3, p. 147, doi. 10.1007/s10928-023-09850-2

By:

Ruiz-Garcia, Ana;
Baverel, Paul;
Bottino, Dean;
Dolton, Michael;
Feng, Yan;
González-García, Ignacio;
Kim, Jaeyeon;
Robey, Seth;
Singh, Indrajeet;
Turner, David;
Wu, Shu-Pei;
Yin, Donghua;
Zhou, Di;
Zhu, Hao;
Bonate, Peter

Publication type:

Article

A mechanistic pharmacokinetic model with drug and antidrug antibody interplay, and its application for assessing the impact of immunogenicity response on bioequivalence testing.

Published in:

British Journal of Clinical Pharmacology, 2020, v. 86, n. 11, p. 2182, doi. 10.1111/bcp.14312

By:

Liao, Kai H.;
Udata, Chandrasekhar;
Yin, Donghua;
Sewell, K. Lea;
Kantaridis, Constantino;
Alvarez, Daniel F.;
Meng, Xu

Publication type:

Article

Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab.

Published in:

British Journal of Clinical Pharmacology, 2016, v. 82, n. 6, p. 1568, doi. 10.1111/bcp.13094

By:

Williams, Jason H.;
Hutmacher, Matthew M.;
Zierhut, Matthew L.;
Becker, Jean ‐ Claude;
Gumbiner, Barry;
Spencer ‐ Green, George;
Melia, Lisa A.;
Liao, Kai ‐ Hsin;
Suster, Matthew;
Yin, Donghua;
Li, Ruifeng;
Meng, Xu

Publication type:

Article

A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis.

Published in:

British Journal of Clinical Pharmacology, 2016, v. 82, n. 1, p. 129, doi. 10.1111/bcp.12916

By:

Cohen, Stanley;
Emery, Paul;
Greenwald, Maria;
Yin, Donghua;
Becker, Jean‐Claude;
Melia, Lisa Ann;
Li, Ruifeng;
Gumbiner, Barry;
Thomas, Dolca;
Spencer‐Green, George;
Meng, Xu

Publication type:

Article

A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers ( REFLECTIONS B327-01).

Published in:

British Journal of Clinical Pharmacology, 2014, v. 78, n. 6, p. 1281, doi. 10.1111/bcp.12464

By:

Yin, Donghua;
Barker, Kerry B.;
Li, Ruifeng;
Meng, Xu;
Reich, Steven D.;
Ricart, Alejandro D.;
Rudin, Dan;
Taylor, Carrie T.;
Zacharchuk, Charles M.;
Hansson, Arne G.

Publication type:

Article

Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework.

Published in:

AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00901-1

By:

Williams, Jason H.;
Liao, Kai H.;
Yin, Donghua;
Meng, Xu

Publication type:

Article

Joint Disposition Properties and Comprehensive Pharmacokinetic Characterization of Antibody–Drug Conjugates.

Published in:

AAPS Journal, 2022, v. 24, n. 4, p. 1, doi. 10.1208/s12248-022-00717-x

By:

Liao, Kai H.;
Williams, Jason H.;
Palani, Santhosh;
Yin, Donghua;
Meng, Xu

Publication type:

Article

Considerations on the Calculation of the Human Equivalent Dose from Toxicology Studies for Biologic Anticancer Agents.

Published in:

2021

By:

Elmeliegy, Mohamed;
Udata, Chandrasekhar;
Liao, Ken;
Yin, Donghua

Publication type:

Editorial

Radiofrequency for Chronic Knee Pain: A Literature Review.

Published in:

Journal of Pain Research, 2025, v. 18, p. 2203, doi. 10.2147/JPR.S512813

By:

Shang, Chao;
Sun, Ning;
Lv, Zixu;
Yin, Donghua;
Feng, Chunlin

Publication type:

Article

Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis.

Published in:

Expert Opinion on Biological Therapy, 2019, v. 19, n. 10, p. 1065, doi. 10.1080/14712598.2019.1635583

By:

Palaparthy, Rameshraja;
Rehman, Muhammad I.;
von Richter, Oliver;
Yin, Donghua

Publication type:

Article

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.

Published in:

Investigational New Drugs, 2020, v. 38, n. 3, p. 800, doi. 10.1007/s10637-019-00830-3

By:

Noel, Marcus;
O'Reilly, Eileen M.;
Wolpin, Brian M.;
Ryan, David P.;
Bullock, Andrea J.;
Britten, Carolyn D.;
Linehan, David C.;
Belt, Brian A.;
Gamelin, Eric C.;
Ganguly, Bishu;
Yin, Donghua;
Joh, Tenshang;
Jacobs, Ira A.;
Taylor, Carrie T.;
Lowery, Maeve A.

Publication type:

Article

Phase I study of oral irinotecan as a single-agent and given sequentially with capecitabine.

Published in:

Investigational New Drugs, 2012, v. 30, n. 1, p. 290, doi. 10.1007/s10637-010-9528-x

By:

Goff, Laura;
Benson, Al;
LoRusso, Patricia;
Tan, Antoinette;
Berlin, Jordan;
Denis, Louis;
Benner, Rebecca;
Yin, Donghua;
Rothenberg, Mace

Publication type:

Article

A Normal Contact Stiffness Statistical Model of Joint Interface considering Hardness Changes.

Published in:

Advances in Materials Science & Engineering, 2022, p. 1, doi. 10.1155/2022/2160508

By:

Yin, Donghua;
Zhang, Xueliang;
Wen, Shuhua;
Lan, Guosheng;
Chen, Yonghui

Publication type:

Article

Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development.

Published in:

CPT: Pharmacometrics & Systems Pharmacology, 2024, v. 13, n. 5, p. 691, doi. 10.1002/psp4.13079

By:

Gao, Wei;
Liu, Jiang;
Shtylla, Blerta;
Venkatakrishnan, Karthik;
Yin, Donghua;
Shah, Mirat;
Nicholas, Timothy;
Cao, Yanguang

Publication type:

Article

PK/PD model‐informed dose selection for oncology phase I expansion: Case study based on PF‐06939999, a PRMT5 inhibitor.

Published in:

CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 11, p. 1619, doi. 10.1002/psp4.12882

By:

Guo, Cen;
Liao, Kai H.;
Li, Meng;
Wang, I‐Ming;
Shaik, Naveed;
Yin, Donghua

Publication type:

Article

Pharmacokinetics and Pharmacodynamics of Figitumumab, a Monoclonal Antibody Targeting the Insulin-Like Growth Factor 1 Receptor, in Healthy Participants.

Published in:

Journal of Clinical Pharmacology, 2013, v. 53, n. 1, p. 21, doi. 10.1177/0091270011432934

By:

Yin, Donghua;
Sleight, Barbara;
Alvey, Christine;
Hansson, Arne G.;
Bello, Akintunde

Publication type:

Article

A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01).

Published in:

Expert Review of Clinical Immunology, 2018, v. 14, n. 4, p. 329, doi. 10.1080/1744666X.2018.1446829

By:

Palaparthy, Ramesh;
Udata, Chandrasekhar;
Hua, Steven Y.;
Yin, Donghua;
Cai, Chun-Hua;
Salts, Stephanie;
Rehman, Muhammad I.;
McClellan, Joseph;
Meng, Xu

Publication type:

Article

Evaluating imbalances of adverse events during biosimilar development.

Published in:

mAbs (1942-0862), 2016, v. 8, n. 5, p. 861, doi. 10.1080/19420862.2016.1171431

By:

Vana, Alicia M.;
Freyman, Amy W.;
Reich, Steven D.;
Yin, Donghua;
Li, Ruifeng;
Anderson, Scott;
Jacobs, Ira A.;
Zacharchuk, Charles M.;
Ewesuedo, Reginald

Publication type:

Article

Statistical Model of Normal Contact Stiffness of Fixed Joint Surface during Unloading after First Loading.

Published in:

Advances in Materials Science & Engineering, 2021, p. 1, doi. 10.1155/2021/6626727

By:

Yin, Donghua;
Zhang, Xueliang;
Chen, Yonghui;
Lan, Guosheng;
Wang, Yanhui;
Wen, Shuhua

Publication type:

Article

Changes in metabolic overweight phenotypes over time and risk of nephrolithiasis: a cohort study.

Published in:

BMC Public Health, 2024, v. 24, n. 1, p. 1, doi. 10.1186/s12889-024-19229-8

By:

Cheng, Yang;
Zheng, Hui;
Yin, Hongli;
Yin, Donghua;
Wang, Hui;
Wang, Ying;
Tang, Qiang;
Gu, Shouyong

Publication type:

Article