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Pharmacokinetic and Pharmacodynamic Equivalence of Biosimilar and Reference Ultra-Rapid Lispro: A Comparative Clamp Study in Healthy Volunteers.
Clin Pharmacol Drug Dev
January 2025
R&D Center, GEROPHARM, Saint-Petersburg, Russia.
Ultra-rapid insulin lispro is an innovative insulin analogue designed to achieve rapid onset and short duration of action, aimed at optimizing glycemic control in patients with diabetes. This was a double-blind, randomized, 2-period, crossover clamp study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD), along with safety profiles, of a potential biosimilar ultra-rapid insulin lispro compared to the reference product in healthy White men. A total of 35 healthy volunteers completed hyperinsulinemic euglycemic clamp procedures across both study periods.
View Article and Find Full Text PDFNewer Insulin Preparations and Insulin Analogs.
Cureus
November 2024
Department of Pharmacology, Krishna Vishwa Vidyapeeth (Deemed to be University), Karad, IND.
Diabetes mellitus represents a significant and growing global health challenge, with its prevalence steadily increasing. Insulin therapy remains a cornerstone of diabetes management. Since its discovery in 1921, insulin has undergone substantial advancements, evolving from crude animal extracts to highly refined recombinant formulations and biosimilars.
View Article and Find Full Text PDFCell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFEfficacy, safety, and immunogenicity of recombinant insulin aspart (BioGenomics Limited) and NovoRapid (Novo Nordisk) in adults with type 2 diabetes mellitus: a randomized, open-label, multicenter, phase-3 study.
Res Pharm Sci
October 2024
BioGenomics Ltd, Maharastra, India.
Background And Purpose: To compare the efficacy, safety, and immunogenicity of recombinant insulin aspart 100 U/mL manufactured by BioGenomics Limited (BGL-ASP) with innovator NovoRapid in type 2 diabetes mellitus patients (T2 DM).
Experimental Approach: This was a multicenter, open-label, randomized, parallel-group study in T2 DM patients, on premix human insulin therapy ± oral anti-diabetics. Besides self-monitored plasma glucose, fasting and post-prandial plasma glucose (FPG and PPG) were tested at baseline, week 12, and week 24.
Safety and Effectiveness of a Biosimilar Recombinant Growth Hormone in Adults with Growth Hormone Deficiency: Analysis of Final Data from PATRO Adults, an International Post-Marketing Surveillance Study.
Drug Des Devel Ther
December 2024
HEXAL AG (a Sandoz company), Holzkirchen, Germany.
Purpose: Long-term studies are needed to investigate the safety of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD) in routine practice. The objective of this study was to evaluate the safety and effectiveness of biosimilar rhGH (somatropin; Omnitrope) in adults with GHD.
Methods: PAtients TReated with Omnitrope (PATRO) Adults was a post-marketing surveillance study conducted across Europe.
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