Cargando…

Evaluation of the physicochemical and biological stability of reconstituted and diluted SB2 (infliximab)

OBJECTIVES: To evaluate the critical quality attributes that might affect the stability of an infliximab biosimilar (SB2, Flixabi) when reconstituted or diluted and stored under refrigeration and at room temperature. METHODS: We largely adhered to the UK's National Health Service guidance requi...

Descripción completa

Detalles Bibliográficos
Autores principales:	Kim, Jihyun, Chung, Jihyun, Park, Sujin, Jung, Saem, Kang, Dukwon
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2018
Materias:	Original Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931250/ https://www.ncbi.nlm.nih.gov/pubmed/29732144 http://dx.doi.org/10.1136/ejhpharm-2016-001085

Ejemplares similares

Extended Stability of Reconstituted and Diluted SB3 (Trastuzumab Biosimilar) Assessed by Physicochemical and Biological Properties
por: Yun, Jihoon, et al.
Publicado: (2019)

Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)
por: Hong, Juyong, et al.
Publicado: (2016)

Physicochemical and Biological Stability Assessment of SB11 (Ranibizumab Biosimilar) Under Ambient and In-Use Storage for Intravitreal Administration
por: Kaiser, Peter K., et al.
Publicado: (2023)

In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period
por: Tak, Minji, et al.
Publicado: (2023)

Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis(®) (Ranibizumab) Biosimilar
por: Kim, Eunji, et al.
Publicado: (2022)

Evaluation of Physicochemical and Biological Stability of 36-Months-Aged SB5 (Adalimumab Biosimilar) for 4 Weeks at Room Temperature
por: Park, Dongkuk, et al.
Publicado: (2018)

Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept
por: Cho, Ick Hyun, et al.
Publicado: (2016)

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars
por: Ebbers, Hans C., et al.
Publicado: (2020)

Stability and microbiological properties of a new formulation of epoprostenol sodium when reconstituted and diluted
por: Lambert, Olivier, et al.
Publicado: (2012)

Determination of Sb(III) and Sb(V) by HPLC—Online isotopic dilution—ICP MS
por: Fontanella, Maria Chiara, et al.
Publicado: (2015)

Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review
por: Corominas, Héctor, et al.
Publicado: (2023)

Lyophilization of Curcumin–Albumin Nanoplex with Sucrose as Cryoprotectant: Aqueous Reconstitution, Dissolution, Kinetic Solubility, and Physicochemical Stability
por: Chua, Angeline, et al.
Publicado: (2022)

Evaluation of the physicochemical and functional stability of diluted REMSIMA(®) upon extended storage—A study compliant with NHS (UK) guidance
por: Young, Benjamin L., et al.
Publicado: (2015)

Postoperative expressive aphasia associated with intravenous midazolam administration: a 5-year retrospective case-control study
por: Oh, Saecheol, et al.
Publicado: (2020)

Reconstitution of disrupted photoreceptor layer in uveitis associated with Behçet’s disease by infliximab treatment
por: Takeuchi, Masaru, et al.
Publicado: (2015)

Aliovalent Dilute Doping and Nano‐Moiré Fringe Advance the Structural Stability and Thermoelectric Performance in β‐Zn(4)Sb(3)
por: Jen, I‐Lun, et al.
Publicado: (2022)

Stability of calcium levofolinate reconstituted in syringes and diluted in NaCl 0.9% and glucose 5% polyolefin/polyamide infusion bags
por: Sanogo, Seydou, et al.
Publicado: (2020)

Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study
por: Smolen, Josef S, et al.
Publicado: (2018)

Altered T cell and monocyte subsets in prolonged immune reconstitution inflammatory syndrome related with DRESS (drug reaction with eosinophilia and systemic symptoms)
por: Kang, Sung-Yoon, et al.
Publicado: (2020)

SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis
por: Goncalves, Joao, et al.
Publicado: (2019)

Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
por: Fautrel, Bruno, et al.
Publicado: (2023)

Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea
por: Kim, Dong W., et al.
Publicado: (2023)

Adalimumab for Corticosteroid and Infliximab-Resistant Immune Reconstitution Inflammatory Syndrome in the Setting of TB/HIV Coinfection
por: Lwin, Nilar, et al.
Publicado: (2018)

1401. Infliximab for Immune Reconstitution Inflammatory Syndrome (IRIS) in Tuberculous Meningitis; A Treatment Paradox
por: Azeem, Ahad, et al.
Publicado: (2021)

Infliximab trough levels are associated with endoscopic healing but not with transmural healing at one year treatment with infliximab in pediatric patients with Crohn’s disease
por: Choi, So Yoon, et al.
Publicado: (2023)

Advanced assessment through intact glycopeptide analysis of Infliximab’s biologics and biosimilar
por: Kim, Hyejin, et al.
Publicado: (2022)

ON THE PHYSICOCHEMICAL REGULATION OF THE GROWTH OF TISSUES : THE EFFECTS OF THE DILUTION OF THE MEDIUM ON THE GROWTH OF THE SPLEEN.
por: Carrel, Alexis, et al.
Publicado: (1911)

A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade(®)) in Healthy Subjects
por: Shin, Donghoon, et al.
Publicado: (2015)

Development of Spinal Tuberculosis in an Adolescent With Crohn's Disease After Infliximab Therapy: A Case Report With Literature Review
por: Jung, Jae Hoon, et al.
Publicado: (2022)

A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy
por: Choe, Jung-Yoon, et al.
Publicado: (2017)

Highly Diluted Glyphosate Mitigates Its Effects on Artemia salina: Physicochemical Implications
por: Nagai, Mirian Yaeko Dias de Oliveira, et al.
Publicado: (2023)

Aliovalent Dilute Doping and Nano‐Moiré Fringe Advance the Structural Stability and Thermoelectric Performance in β‐Zn(4)Sb(3) (Adv. Sci. 26/2022)
por: Jen, I‐Lun, et al.
Publicado: (2022)

PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients
por: Martinez-Vinson, Christine, et al.
Publicado: (2022)

Lattice position and thermal stability of diluted As in Ge
por: Decoster, S, et al.
Publicado: (2012)

Physicochemical Study of the Molecular Signal Transfer of Ultra-High Diluted Antibodies to Interferon-Gamma
por: Jerman, Igor, et al.
Publicado: (2023)

Evolutionary biology at BGRS\SB-2016
por: Baranova, Ancha V., et al.
Publicado: (2017)

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results
por: Smolen, Josef S., et al.
Publicado: (2017)

Comparison of Long-term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naïve Patients with Ulcerative Colitis
por: Lee, Yong Il, et al.
Publicado: (2021)

On the decay of 110Sb, 111Sb, 112Sb, 113Sb and 114Sb
por: Sunier, J W, et al.
Publicado: (1970)

Biological Responses to Diesel Exhaust Particles (DEPs) Depend on the Physicochemical Properties of the DEPs
por: Park, Eun-Jung, et al.
Publicado: (2011)

Cannot write session to /tmp/vufind_sessions/sess_ev19u1hai5fe70b8brkdhdpe4k