Proposing a framework to quantify the potential impact of pharmacokinetic drug–drug interactions caused by a new drug candidate by using real world data about the target patient population
Dagenais, Simon, Lee, Christine, Cronenberger, Carol, Wang, Ellen, Sahasrabudhe, Vaishali
Published in Clinical and translational science (01.03.2024)
Published in Clinical and translational science (01.03.2024)
Get full text
Journal Article
A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis
Fleischmann, Roy M, Alten, Rieke, Pileckyte, Margarita, Lobello, Kasia, Hua, Steven Y, Cronenberger, Carol, Alvarez, Daniel, Bock, Amy E, Sewell, K Lea
Published in Arthritis research & therapy (15.08.2018)
Published in Arthritis research & therapy (15.08.2018)
Get full text
Journal Article
Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52–92 data from a randomized, double-blind, phase 3 trial
Fleischmann, Roy M, Alvarez, Daniel F, Bock, Amy E, Cronenberger, Carol, Vranic, Ivana, Zhang, Wuyan, Alten, Rieke
Published in Arthritis research & therapy (25.09.2021)
Published in Arthritis research & therapy (25.09.2021)
Get full text
Journal Article
Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects
Cox, Donna S., Alvarez, Daniel F., Bock, Amy E., Cronenberger, Carol L.
Published in Clinical pharmacology in drug development (01.10.2021)
Published in Clinical pharmacology in drug development (01.10.2021)
Get full text
Journal Article
Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study
Landen, Jaren W, Andreasen, Niels, Cronenberger, Carol L, Schwartz, Pamela F, Börjesson-Hanson, Anne, Östlund, Henrik, Sattler, Catherine A, Binneman, Brendon, Bednar, Martin M
Published in Alzheimer's & dementia : translational research & clinical interventions (01.09.2017)
Published in Alzheimer's & dementia : translational research & clinical interventions (01.09.2017)
Get full text
Journal Article
Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26–52, including a treatment switch from reference ADL to PF-06410293
Fleischmann, Roy M, Alvarez, Daniel F, Bock, Amy E, Cronenberger, Carol, Vranic, Ivana, Zhang, Wuyan, Alten, Rieke
Published in Rheumatic & musculoskeletal diseases open (01.04.2021)
Published in Rheumatic & musculoskeletal diseases open (01.04.2021)
Get full text
Journal Article
Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54
Alten, Rieke, Batko, Bogdan, Hala, Tomas, Kameda, Hideto, Radominski, Sebastiao C, Tseluyko, Vira, Babic, Goran, Cronenberger, Carol, Hackley, Sarah, Rehman, Muhammad, von Richter, Oliver, Zhang, Min, Cohen, Stanley
Published in Rheumatic & musculoskeletal diseases open (01.03.2019)
Published in Rheumatic & musculoskeletal diseases open (01.03.2019)
Get full text
Journal Article
Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy
Landen, Jaren W, Cohen, Sharon, Billing, Clare B, Cronenberger, Carol, Styren, Scot, Burstein, Aaron H, Sattler, Catherine, Lee, Jae-Hong, Jack, Clifford R, Kantarci, Kejal, Schwartz, Pamela F, Duggan, William T, Zhao, Qinying, Sprenger, Ken, Bednar, Martin M, Binneman, Brendon
Published in Alzheimer's & dementia : translational research & clinical interventions (01.09.2017)
Published in Alzheimer's & dementia : translational research & clinical interventions (01.09.2017)
Get full text
Journal Article
Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
Alvarez, Daniel F., Wolbink, Gertjan, Cronenberger, Carol, Orazem, John, Kay, Jonathan
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.12.2020)
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.12.2020)
Get full text
Journal Article
Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin®) in patients with advanced non-squamous non-small cell lung cancer
Li, Cheryl S. W., Sweeney, Kevin, Cronenberger, Carol
Published in Cancer chemotherapy and pharmacology (01.03.2020)
Published in Cancer chemotherapy and pharmacology (01.03.2020)
Get full text
Journal Article
Extension Study of PF‐05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis
Cohen, Stanley B., Burgos‐Vargas, Rubén, Emery, Paul, Jin, Bo, Cronenberger, Carol, Vázquez‐Abad, María‐Dolores
Published in Arthritis care & research (2010) (01.11.2018)
Published in Arthritis care & research (2010) (01.11.2018)
Get full text
Journal Article
Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial
Cohen, Stanley B., Radominski, Sebastiao C., Kameda, Hideto, Kivitz, Alan J., Tee, Michael, Cronenberger, Carol, Zhang, Min, Hackley, Sarah, Rehman, Muhammad I., von Richter, Oliver, Alten, Rieke
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.04.2020)
Published in BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy (01.04.2020)
Get full text
Journal Article
Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study
Fleischmann, Roy M, Saikali, Wassim, Lakhanpal, Sharad, Alvarez, Daniel F, Cox, Donna S, Ianos, Claudia Ana, Zhang, Wuyan, Cronenberger, Carol, Wang, Karen
Published in The Lancet. Rheumatology (01.09.2023)
Published in The Lancet. Rheumatology (01.09.2023)
Get more information
Journal Article
Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis
Fleischmann, Roy M., Bock, Amy E., Zhang, Wuyan, Godfrey, Charles M., Vranic, Ivana, Cronenberger, Carol, Dokoupilová, Eva
Published in Rheumatology and therapy. (01.06.2022)
Published in Rheumatology and therapy. (01.06.2022)
Get full text
Journal Article
Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer's disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study
Miyoshi, Izuru, Fujimoto, Yoko, Yamada, Masahito, Abe, Sadahiro, Zhao, Qinying, Cronenberger, Carol, Togo, Kanae, Ishibashi, Taro, Bednar, Martin M, Kupiec, James W, Binneman, Brendon
Published in International journal of clinical pharmacology and therapeutics (01.12.2013)
Published in International journal of clinical pharmacology and therapeutics (01.12.2013)
Get more information
Journal Article
How Current Understanding of Clearance Mechanisms and Pharmacodynamics of Therapeutic Proteins Can Be Applied for Evaluation of Their Drug-Drug Interaction Potential
KRAYNOV, Eugenia, MARTIN, Steven W, AWWAD, Michel, WANG, Diane, HURST, Susan, FAHMI, Odette A, DOWTY, Martin, CRONENBERGER, Carol, LOI, Cho-Ming, KUANG, Bing, FIELDS, Owen, FOUNTAIN, Scott
Published in Drug metabolism and disposition (01.10.2011)
Published in Drug metabolism and disposition (01.10.2011)
Get full text
Journal Article
O3‐13‐04: Effect of acute anti‐amyloid monoclonal antibody ponezumab (PF‐04360365) dosing on Aβ fractional clearance rate in subjects with mild Alzheimer's disease and in healthy volunteers
Raunig, David, Burstein, Aaron, Cronenberger, Carol, Andreasen, Niels, Lopez, Rene, Kupiec, James, Bednar, Martin
Published in Alzheimer's & dementia (01.07.2012)
Published in Alzheimer's & dementia (01.07.2012)
Get full text
Journal Article
Effect of acute anti-amyloid monoclonal antibody ponezumab (PF-04360365) dosing on Aβ fractional clearance rate in subjects with mild Alzheimer's disease and in healthy volunteers
Raunig, David, Burstein, Aaron, Cronenberger, Carol, Andreasen, Niels, Lopez, Rene, Kupiec, James, Bednar, Martin
Published in Alzheimer's & dementia (01.07.2012)
Published in Alzheimer's & dementia (01.07.2012)
Get full text
Journal Article