Results 41 to 50 of about 790,096 (261)

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

Assessing the exposure risk and impacts of pharmaceuticals in the environment on individuals and ecosystems [PDF]

, 2013
Copyright @ 2013 The authors. Published by the Royal Society under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/3.0/, which permits unrestricted use, provided the original author and source are credited.The
Boxall, A.B.A., Cuthbert, Richard, Madden, J. C., Shore, R.F., Arnold, KE, Brown, A.R., Naidoo, V, Boxall, AB, Gaw, Sally, Taggart, MA, Shore, R. F., Brown, A. R., Thompson, HM, Naidoo, V., Metcalfe, CD, Cuthbert, R. J., Arnold, Kathryn E., Metcalfe, Chis D., Cuthbert, R.J., Gaw, S, Taggart, M.A., Metcalfe, C. D., Arnold, K. E., Thompson, H.M., Madden, J.C., Smits, JE, Hutchinson, Thomas H., Jobling, S, Jobling, Susan, Brown, AR, Jobling, S., Thompson, H. M., Madden, Judith C., Thompson, Helen M., Cuthbert, RJ, Brown, A. Ross, Arnold, K.E., Hutchinson, T. H., Taggart, Mark A., Shore, RF, Cuthbert, Richard J., Smits, J.E., Naidoo, Vinny, Shore, Richard F., Boxall, A. B. A., Boxall, ABA, Metcalfe, Chris D., Gaw, S., Smits, Judit E., Madden, JC, Metcalfe, C.D., Boxall, Alistair B.A., Smits, J. E., Hutchinson, T.H., Taggart, M. A., Hutchinson, TH   +55 more
core   +1 more source

Biosimilar Drugs for Therapy of Immune-Mediated Diseases

, 2018
In recent years, biological therapy has been widely used for the treatment of immunemediated diseases in rheumatology, hematology, gastroenterology, etc.
Tsvetelina Velikova
core   +1 more source

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

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

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

Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision

Frontiers in Medicine, 2020
Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is
R. Gaspar, B. Silva‐Lima, F. Magro, A. Alcobia, F. L. da Costa, J. Feio   +5 more
semanticscholar   +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

Biological and Biosimilar Medicines in Contemporary Pharmacotherapy for Metabolic Syndrome

Pharmaceutics
The discovery of new drugs offers valuable alternatives, particularly for treating diseases that are resistant to existing therapies or involving complex, multi-organ conditions such as metabolic syndrome. Although treatment algorithms are generally well
Wiktoria Górecka, Daria Berezovska, Monika Mrozińska, Grażyna Nowicka, M. Czerwińska   +4 more
semanticscholar   +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