Works matching AU Cronenberger, Carol

Results: 17

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.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 10, p. 1166, doi. 10.1002/cpdd.939

By:

Cox, Donna S.;
Alvarez, Daniel F.;
Bock, Amy E.;
Cronenberger, Carol L.

Publication type:

Article

Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin<sup>®</sup>) in patients with advanced non-squamous non-small cell lung cancer.

Published in:

2020

By:

Li, Cheryl S. W.;
Sweeney, Kevin;
Cronenberger, Carol

Publication type:

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.

Published in:

Arthritis Research & Therapy, 2018, v. 20, n. 1, p. N.PAG, doi. 10.1186/s13075-018-1676-y

By:

Fleischmann, Roy M.;
Alten, Rieke;
Pileckyte, Margarita;
Lobello, Kasia;
Hua, Steven Y.;
Cronenberger, Carol;
Alvarez, Daniel;
Bock, Amy E.;
Sewell, K. Lea

Publication type:

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.

Published in:

International Journal of Clinical Pharmacology & Therapeutics, 2013, v. 51, n. 12, p. 911, doi. 10.5414/CP201816

By:

Izuru Miyoshi;
Yoko Fujimoto;
Masahito Yamada;
Abe, Sadahiro;
Qinying Zhao;
Cronenberger, Carol;
Kanae Togo;
Taro Ishibashi;
Bednar, Martin M.;
Kupiec, James W.;
Binneman, Brendon

Publication type:

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

Published in:

Arthritis Research & Therapy, 2021, v. 23, n. 1, p. 1, doi. 10.1186/s13075-021-02626-4

By:

Fleischmann, Roy M.;
Alvarez, Daniel F.;
Bock, Amy E.;
Cronenberger, Carol;
Vranic, Ivana;
Zhang, Wuyan;
Alten, Rieke

Publication type:

Article

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.

Published in:

CTS: Clinical & Translational Science, 2024, v. 17, n. 3, p. 1, doi. 10.1111/cts.13741

By:

Dagenais, Simon;
Lee, Christine;
Cronenberger, Carol;
Wang, Ellen;
Sahasrabudhe, Vaishali

Publication type:

Article

Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

Published in:

BioDrugs, 2020, v. 34, n. 6, p. 723, doi. 10.1007/s40259-020-00446-7

By:

Alvarez, Daniel F.;
Wolbink, Gertjan;
Cronenberger, Carol;
Orazem, John;
Kay, Jonathan

Publication type:

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

Published in:

BioDrugs, 2020, v. 34, n. 2, p. 197, doi. 10.1007/s40259-019-00403-z

By:

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

Publication type:

Article

Population pharmacokinetic analysis of carboxyhaemoglobin concentrations in adult cigarette smokers.

Published in:

British Journal of Clinical Pharmacology, 2008, v. 65, n. 1, p. 30, doi. 10.1111/j.1365-2125.2007.02974.x

By:

Cronenberger, Carol;
Mould, Diane R.;
Roethig, Hans-Juergen;
Sarkar, Mohamadi

Publication type:

Article

The Hepatic First-Pass Metabolism of Problematic Drugs.

Published in:

1993

By:

Lalka, David;
Griffith, Robert K.;
Cronenberger, Carol L.

Publication type:

Other

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.

Published in:

Rheumatology & Therapy, 2022, v. 9, n. 3, p. 839, doi. 10.1007/s40744-022-00439-8

By:

Fleischmann, Roy M.;
Bock, Amy E.;
Zhang, Wuyan;
Godfrey, Charles M.;
Vranic, Ivana;
Cronenberger, Carol;
Dokoupilová, Eva

Publication type:

Article

Exposure-response modeling and clinical trial simulation of the effect of tolterodine on QT intervals in healthy volunteers.

Published in:

Drug Discoveries & Therapeutics, 2010, v. 4, n. 1, p. 44

By:

Sweeney, Kevin R.;
Gastonguay, Marc R.;
Benincosa, Lisa;
Cronenberger, Carol L.;
Glue, Paul;
Malhotra, Bimal K.

Publication type:

Article

Safety, tolerability, pharmacokinetics and pharmacodynamics of monthly and quarterly doses of Ponezumab (PF-04360365) in subjects with mild-to-moderate Alzheimer's disease

Published in:

2012

By:

Landen, Jaren;
Andreasen, Niels;
Cronenberger, Carol;
Schwartz, Pam;
Börjesson-Hanson, Anne;
Östlund, Henrik;
Sattler, Catherine;
Kupiec, James;
Binneman, Brendon;
Bednar, Martin

Publication type:

Abstract

Safety, efficacy, pharmacokinetics and pharmacodynamics of multiple doses of Ponezumab in subjects with mild-to-moderate Alzheimer's disease

Published in:

2012

By:

Landen, Jaren;
Cohen, Sharon;
Billing, Clare;
Cronenberger, Carol;
Styren, Scot;
Burstein, Aaron;
Sattler, Catherine;
Lee, Jae-Hong;
Jack, Clifford;
Bednar, Martin

Publication type:

Abstract

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

Published in:

2012

By:

Raunig, David;
Burstein, Aaron;
Cronenberger, Carol;
Andreasen, Niels;
Lopez, Rene;
Kupiec, James;
Bednar, Martin

Publication type:

Abstract

Effect of ponezumab on CSF biomarkers: Pooled analysis of phase IIa studies in subjects with mild-to-moderate Alzheimer's disease

Published in:

2012

By:

Cronenberger, Carol;
Schwartz, Pam;
Wright, Kathryn;
Bales, Kelly;
Blennow, Kaj;
Zetterberg, Henrik;
Landen, Jaren;
Styren, Scot;
Chen, Nathan;
Binneman, Brendon

Publication type:

Abstract

Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis.

Published in:

2018

By:

Cohen, Stanley B.;
Burgos‐Vargas, Rubén;
Emery, Paul;
Jin, Bo;
Cronenberger, Carol;
Vázquez‐Abad, María‐Dolores;
Burgos-Vargas, Rubén;
Vázquez-Abad, María-Dolores

Publication type:

journal article