Abhijit Barve
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View article: ChemoID-guided therapy improves objective response rate in recurrent platinum-resistant ovarian cancer randomized clinical trial
ChemoID-guided therapy improves objective response rate in recurrent platinum-resistant ovarian cancer randomized clinical trial Open
View article: Seasonal incidence of tobacco leaf eating caterpillar, Spodoptera litura (FAB.) infesting groundnut (Arachis hypogaea L.)
Seasonal incidence of tobacco leaf eating caterpillar, Spodoptera litura (FAB.) infesting groundnut (Arachis hypogaea L.) Open
View article: Population dynamics of invasive tomato leaf miner Tuta absoluta (Meyrick) under open field condition
Population dynamics of invasive tomato leaf miner Tuta absoluta (Meyrick) under open field condition Open
View article: Population dynamics of new invasive black thrips (Thrips parvispinus KARNZ) infesting chilli under open field conditions
Population dynamics of new invasive black thrips (Thrips parvispinus KARNZ) infesting chilli under open field conditions Open
View article: Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema
Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema Open
Importance Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME). Objective…
View article: Erratum to “The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial” [Contemporary Clinical Trials 131 (2023) 107274]
Erratum to “The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial” [Contemporary Clinical Trials 131 (2023) 107274] Open
View article: The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial
The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial Open
View article: 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
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 Open
MYL-1601D demonstrated similar immunogenicity, efficacy, and safety profiles to Ref-InsAsp-US in patients with T1D over 24 weeks. CLINICAL TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03760068.
View article: Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar <scp>MYL‐1601D</scp> with <scp>US</scp> and <scp>European</scp> insulin aspart in healthy volunteers: A randomized, double‐blind, crossover, euglycaemic glucose clamp study
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar <span>MYL‐1601D</span> with <span>US</span> and <span>European</span> insulin aspart in healthy volunteers: A randomized, double‐blind, crossover, euglycaemic glucose clamp study Open
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, randomize…
View article: Author response for "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"
Author response for "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" Open
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, randomize…
View article: 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
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 Open
View article: Physicochemical and functional characterization of MYL-1501D, a proposed biosimilar to insulin glargine
Physicochemical and functional characterization of MYL-1501D, a proposed biosimilar to insulin glargine Open
Insulin glargine is a long-acting analogue of human insulin that has been used to manage hyperglycemia in patients with diabetes mellitus (DM) for nearly 20 years. Insulin glargine has a relatively constant concentration-time profile that …
View article: Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer
Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer Open
Purpose The phase 3 HERITAGE trial demonstrated that the biosimilar trastuzumab-dkst is well tolerated with similar efficacy (measured by overall response rate [ORR] and progression-free survival [PFS]) compared with originator trastuzumab…
View article: A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab
A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab Open
Purpose Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor-specific angiogenesis in some cancers. MYL-1402O is a proposed bevacizumab biosimilar. Methods The primary objective of thi…
View article: Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial
Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial Open
View article: 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
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 Open
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. Patients and meth…
View article: Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL‐1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus
Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL‐1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus Open
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 study compar…
View article: Efficacy and safety of MYL‐1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study
Efficacy and safety of MYL‐1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study Open
Aims To assess the efficacy, insulin dose, safety and immunogenicity when people with type 1 diabetes mellitus switched between MYL‐1501D and reference insulin glargine (Lantus®; Sanofi‐Aventis US LLC, Bridgewater, New Jersey). Materials a…
View article: Author response for "Efficacy and Safety of MYL‐1501D Versus Insulin Glargine in Patients With Type 1 Diabetes Mellitus: Results of the INSTRIDE 3 Phase 3 Switch Study"
Author response for "Efficacy and Safety of MYL‐1501D Versus Insulin Glargine in Patients With Type 1 Diabetes Mellitus: Results of the INSTRIDE 3 Phase 3 Switch Study" Open
View article: Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia Open
Pegfilgrastim is indicated for reducing the duration of neutropenia and incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy. Here, safety and efficacy of MYL-1401H, a proposed pegfilgrastim biosimilar, were invest…
View article: Efficacy and safety of MYL‐1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study
Efficacy and safety of MYL‐1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study Open
Aims To assess the non‐inferiority of MYL‐1501D, a proposed biosimilar or follow‐on biological agent to marketed insulin glargine, to reference insulin glargine (Lantus®; Sanofi‐Aventis US LLC, Bridgewater, New Jersey) based on change in g…
View article: A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL‐1401O <i>vs</i>. EU‐trastuzumab and US‐trastuzumab
A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL‐1401O <i>vs</i>. EU‐trastuzumab and US‐trastuzumab Open
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 trastuzumab biosimilar. Here, …
View article: A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim Open
View article: Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer
Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer Open
Treatment with the anti-ERBB2 humanized monoclonal antibody trastuzumab and chemotherapy significantly improves outcome in patients with ERBB2 (HER2)-positive metastatic breast cancer; a clinically effective biosimilar may help increase ac…
View article: A pharmacokinetics and pharmacodynamics equivalence trial of proposed pegfilgrastim biosimilar, MYL-1401H vs EU neulasta® and US neulasta®
A pharmacokinetics and pharmacodynamics equivalence trial of proposed pegfilgrastim biosimilar, MYL-1401H vs EU neulasta® and US neulasta® Open
View article: Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-neulasta® in the prophylaxis of chemotherapy-induced neutropenia
Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-neulasta® in the prophylaxis of chemotherapy-induced neutropenia Open
View article: Heritage, a phase III safety and efficacy trial of the proposed trastuzumab biosimilar, Myl-1401O vs trastuzumab
Heritage, a phase III safety and efficacy trial of the proposed trastuzumab biosimilar, Myl-1401O vs trastuzumab Open