Alpha 2.0
Login Register
» Authors » Charles Donnelly

Charles Donnelly

Explore the profile of Charles Donnelly including associated specialties, affiliations and a list of published articles. Areas
Snapshot
Articles 6
Citations 27
Followers 0
Related Specialties
Endocrinology
Pharmacology
Oncology
Top 10 Co-Authors
Abhijit Barve
Yaron Raiter
Gopinath Ranganna
Nilanjan Sengupta
Anita Rao
Bin Sun
Patrick Aubonnet
Anoop Chullikana
Cornelius F Waller
Roxann Shapiro
Published In
Diabetes Obes Metab
Br J Clin Pharmacol
Ther Adv Med Oncol
BioDrugs
BMC Endocr Disord
Affiliations
Soon will be listed here.
Recent Articles
1.
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study
Blevins T, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, et al.
BioDrugs . 2022 Sep; 36(6):761-772. PMID: 36114990
Background: MYL-1601D is a proposed biosimilar of originator insulin aspart, Novolog/NovoRapid (Ref-InsAsp-US/Ref-InsAsp-EU). Objective: This study assessed the immunogenicity, efficacy, and safety of MYL-1601D with Ref-InsAsp-US in patients with type 1...
2.
Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer
Socinski M, Waller C, Idris T, Bondarenko I, Luft A, Beckmann K, et al.
Ther Adv Med Oncol . 2021 Nov; 13:17588359211045845. PMID: 34819997
Purpose: This phase III study compared the efficacy and safety of proposed biosimilar MYL-1402O with reference bevacizumab (BEV), as first-line treatment for patients with stage IV non-squamous non-small-cell lung cancer....
3.
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study
Hovelmann U, Raiter Y, Chullikana A, Liu M, Donnelly C, Lawrence T, et al.
Diabetes Obes Metab . 2021 Aug; 23(12):2670-2678. PMID: 34378861
Aim: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence (BE) of MYL-1601D biosimilar with originator, NovoLog (Ref-InsAsp-US), and NovoRapid (Ref-InsAsp-EU). Materials And Methods: This was a double-blind, randomized, crossover...
4.
Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies
Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy A, et al.
BMC Endocr Disord . 2021 Jun; 21(1):129. PMID: 34174848
Background: MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials....
5.
Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus
Heise T, Donnelly C, Barve A, Aubonnet P
Diabetes Obes Metab . 2019 Nov; 22(4):521-529. PMID: 31724253
Aims: To report phase 1 bioequivalence results comparing MYL-1501D, US reference insulin glargine (US IG), and European reference insulin glargine (EU IG). Materials And Methods: The double-blind, randomized, three-way crossover...
6.
A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab
Waller C, Vutikullird A, Lawrence T, Shaw A, Liu M, Baczkowski M, et al.
Br J Clin Pharmacol . 2018 Jun; 84(10):2336-2343. PMID: 29926514
Aims: Trastuzumab is a humanized monoclonal antibody that binds the human epidermal growth factor receptor 2 (HER2) oncoprotein and is an effective therapy for HER2-overexpressing breast cancer. MYL-1401O is a...