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

por Chen, Xiaoying, Li, Cheryl, Ewesuedo, Reginald, Yin, Donghua
Publicado 2019

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

por Chen, Xiaoying, Li, Cheryl, Ewesuedo, Reginald, Yin, Donghua
Publicado 2019

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

por Elmeliegy, Mohamed, Udata, Chandrasekhar, Liao, Ken, Yin, Donghua
Publicado 2021

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

por Guo, Cen, Liao, Kai H., Li, Meng, Wang, I‐Ming, Shaik, Naveed, Yin, Donghua
Publicado 2022

Association between serum uric acid/HDL-cholesterol ratio and chronic kidney disease: a cross-sectional study based on a health check-up population

por Cheng, Yang, Zhang, Hao, Zheng, Hui, Yin, Hongli, Wang, Ying, Wang, Hui, Gu, Liubao, Yin, Donghua
Publicado 2022

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

por Liao, Kai H., Udata, Chandrasekhar, Yin, Donghua, Sewell, K. Lea, Kantaridis, Constantino, Alvarez, Daniel F., Meng, Xu
Publicado 2020

Evaluating imbalances of adverse events during biosimilar development

por Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Publicado 2016

Time trend of cardiometabolic risk factors over a 10-year period in the office-working population in China

por Cheng, Yang, Yin, Hongli, Zheng, Hui, Yin, Donghua, Yin, Gang, Ying, Shanping, Li, Xiaohong, Dai, Hui, Zhao, Lvkun, Shen, Chong, Shen, Zhixiang, Gu, Liubao
Publicado 2019

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

por 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
Publicado 2016

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

por 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
Publicado 2016

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

por 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
Publicado 2023

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

por 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
Publicado 2018

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 meta...

por 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.
Publicado 2019