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1.
Article in English | MEDLINE | ID: mdl-39025231

ABSTRACT

OBJECTIVE: To compare the accuracy of Kane, Barrett Universal II, Haigis, and SRK-T formulas in eyes with average keratometry greater than 46 diopters (D). METHODS: A retrospective analysis was conducted on 101 eyes of 101 patients with average keratometry greater than 46 D. The absolute prediction error (EA) was obtained for each patient one month after surgery. The mean absolute prediction error (MEA), median absolute prediction error (MedEA) and the percentage of patients with absolute refractive error less than 0.25 D, 0.50 D, and 1.00 D were calculated for each formula analyzed. RESULTS: The Kane formula achieved the lowest MEA (0.53 ±â€¯0.43) and the lowest MedEA (0.41), followed by Barrett Universal II (MEA: 0.56 ±â€¯0.42, MedEA: 0.49), SRK-T (MEA: 0.59 ±â€¯0.44, MedEA: 0.54), and Haigis (MEA: 0.77 ±â€¯0.47, MedEA: 0.69), showing a significant difference in the results. It was also observed that the Kane formula was the most accurate, with the highest percentage of patients, with EA less than 0.25 D, 0.50 D, and 1.00 D (30.7%, 54.4%, and 86.1%, respectively), while the Haigis formula was the least accurate (12.9%, 33.7%, and 69.3%, respectively). CONCLUSION: In eyes with corneas having average keratometry greater than 46 D, the Kane formula proves to be a useful tool in intraocular lens (IOL) power calculation and demonstrates higher precision compared to the Barrett Universal II, SRK-T, and Haigis formulas.

2.
Eur J Pharm Sci ; 102: 35-45, 2017 May 01.
Article in English | MEDLINE | ID: mdl-28188909

ABSTRACT

Infliximab is therapeutic monoclonal antibody (mAb) against TNF-α employed in the treatment of immunoinflammatory diseases. The development of biosimilar mAbs is a global strategy to increase drug accessibility and reduce therapy-associated costs. Herein we compared key physicochemical characteristics and biological activities produced by infliximab and infliximab-Probiomed in order to identify functionally relevant differences between the mAbs. Binding of infliximab-Probiomed to TNF-α was specific and had kinetics comparable to that of the reference product. Both mAbs had highly similar neutralizing efficacy in HUVEC cell cultures stimulated with TNF-α. In vitro induction of CDC and ADCC were also similar between the evaluated products. In vivo comparability was assessed using a transgenic mouse model of arthritis that expresses human TNF-α in a 13-week multiple-administration study. Infliximab and infliximab-Probiomed showed comparable efficacy, safety, and pharmacokinetic profiles. Our results indicate that infliximab-Probiomed has highly similar activities to infliximab in preclinical models, warranting a clinical evaluation of its biosimilarity.


Subject(s)
Antirheumatic Agents , Biosimilar Pharmaceuticals , Infliximab , Animals , Antirheumatic Agents/pharmacokinetics , Antirheumatic Agents/pharmacology , Antirheumatic Agents/therapeutic use , Arthritis/drug therapy , Arthritis/metabolism , Biosimilar Pharmaceuticals/pharmacokinetics , Biosimilar Pharmaceuticals/pharmacology , Biosimilar Pharmaceuticals/therapeutic use , CHO Cells , Cells, Cultured , Cricetulus , Cytokines/genetics , Cytokines/metabolism , E-Selectin/metabolism , HEK293 Cells , Human Umbilical Vein Endothelial Cells/drug effects , Human Umbilical Vein Endothelial Cells/metabolism , Humans , Infliximab/pharmacokinetics , Infliximab/pharmacology , Infliximab/therapeutic use , Intercellular Adhesion Molecule-1/metabolism , Male , Mice , Mice, Transgenic , Vascular Cell Adhesion Molecule-1/metabolism
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