Results 21 to 30 of about 166 (149)

Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study [PDF]

Separations, 2019
In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method for the comparative analytical assessment in biosimilar studies. In this process, several reference product lots are necessary, selected from a wide period of manufacturing dates with different shelf lives, to calculate the total variability expressed as the ...
Oliva Martín, Alexis Manuel, Llabrés Martínez, Matías Antonio   +1 more
openaire   +3 more sources

Revisión de dosieres de heparina y enoxaparina: incumplimiento de la normativa de Costa Rica para el registro sanitario de biosimilares farmacéuticos

Ars Pharmaceutica
RESUMEN Objetivo: Determinar los aspectos esenciales de la reglamentación de Costa Rica referente al registro sanitario de biosimilares y compararlos con la información brindada en los dosieres de laboratorios fabricantes de heparina y enoxaparina ...
Rebeca Álvarez Brenes, Keren Zuñiga Villalobos, Jorge Andrés Pacheco Molina, Juan José Mora Román   +3 more
doaj   +1 more source

Intensive Safety Monitoring of Rituximab (Biosimilar Novex® and the Innovator) in Pediatric Patients With Complex Diseases

Frontiers in Pharmacology, 2022
Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex ...
Natalia Riva, Natalia Riva, Manuel Molina, Berta L. Cornaló, María V. Salvador, Andrea Savransky, Silvia Tenembaum, María M. Katsicas, Marta Monteverde, Paulo Cáceres Guido, Paulo Cáceres Guido, Marcela Rousseau, Raquel Staciuk, Agustín González Correas, Pedro Zubizarreta, Oscar Imventarza, Eduardo Lagomarsino, Eduardo Spitzer, Marcelo Tinelli, Paula Schaiquevich, Paula Schaiquevich   +20 more
doaj   +1 more source

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries

Frontiers in Pharmacology, 2017
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries ...
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I. Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Andras Harsanyi, Pero Draganic   +11 more
doaj   +1 more source

Long-Acting Opioid Analgesics for Acute Pain: Pharmacokinetic Evidence Reviewed

Veterinary Sciences, 2023
Long-acting injectable (LAI) opioid formulations mitigate the harm profiles and management challenges associated with providing effective analgesia for animals. A single dose of a long-acting opioid analgesic can provide up to 72 h of clinically relevant
Betty M. Tyler, Michael Guarnieri
doaj   +1 more source

Population Pharmacokinetic Modeling of TV-46000, a Risperidone Long-Acting Subcutaneous Antipsychotic for the Treatment of Patients with Schizophrenia

Neurology and Therapy
Introduction TV-46000 is a long-acting subcutaneous antipsychotic (LASCA) agent that combines risperidone and an innovative, copolymer-based drug delivery technology in a suspension suitable for subcutaneous administration from a prefilled syringe.
Itay Perlstein, Avia Merenlender Wagner, Anna Elgart, Anthe S. Zandvliet, Farina Hellmann, YuWei Lin, Eline van Maanen, Nele Plock, Floris Fauchet, Rajendra Singh   +9 more
doaj   +1 more source

Coverage Generosity of Novel Antirheumatic Drugs in Medicare Advantage and Stand‐Alone Part D Plans

Arthritis &Rheumatology, EarlyView.
Objective We examine coverage of self‐administered disease‐modifying antirheumatic drugs (DMARDs) in Medicare Part D. Methods Using 2022–2026 Part D formulary data, we assessed coverage of the following DMARD classes that treat relapsed rheumatoid arthritis (RA): tumor necrosis factor (TNF) inhibitors, T cell costimulatory modulator, interleukin‐6 (IL ...
Youngmin Kwon, Robert W. Corty, Stacie B. Dusetzina   +2 more
wiley   +1 more source

Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab

Тонкие химические технологии, 2020
Objectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials.
D. I. Zybin, A. S. Seregin, A. D. Askretkov, N. V. Orlova, Yu. A. Seregin, A. I. Prostyakova, D. V. Kapustin   +6 more
doaj   +1 more source

Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab

Indian Journal of Ophthalmology, 2021
Purpose: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular ...
Lalit Verma, Mithun Thulasidas, Ajay Purohit, Avnindra Gupta, Ritesh Narula, Dinesh Talwar   +5 more
doaj   +1 more source

Non‐melanoma skin cancer risk with Janus kinase inhibitors compared to interleukin‐6 receptor inhibitors in rheumatoid arthritis: results from a national cohort study

Arthritis &Rheumatology, Accepted Article.
Background Non‐melanoma skin cancer (NMSC) is one of the most common malignancies in rheumatoid arthritis (RA). This analysis assessed NMSC risk with Janus kinase inhibitors (JAKi) compared to interleukin‐6 receptor inhibitors (IL‐6Ri). Method This study used data from the British Society for Rheumatology Rheumatoid Arthritis Register (BSRBR‐RA) linked
Zixing Tian, Lianne Kearsley‐Fleet, Sizheng Steven Zhao, James Galloway, Mark Lunt, Kath Watson, Narges Azadbakht, BSRBR‐RA Contributors Group, Kimme L Hyrich   +8 more
wiley   +1 more source