Results 31 to 40 of about 5,574 (244)
Ars PharmaceuticaRESUMEN 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 +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 +11 more
doaj +1 more source
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 +1 more
openaire +3 more sources
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
Review of medicine registration system in Tanzania [PDF]
, 2019 Philosophiae Doctor - PhDRegistration of medicines is an essential function of the national medicine regulatory system of any country. Since the start of the medicine registration system in Tanzania in early 2000s, no systematic review has been carried
KISOMA, SUNDAY
core +3 more sources
Pharmaceutical advice by phone enhances use of infliximab biosimilars
, 2018 25.
van Eijk, SC, Arndt, LK, Neitemeier, S
openaire +2 more sources
European Journal of Pharmaceutical Sciences, 2022 Pharmaceutical development of biosimilars is primarily focused on meeting the regulatory requirements for analytical comparability of the product's critical quality attributes (CQAs), concerning safety and efficacy, to those of the originator drug of interest.
Morteza Jaffar-Aghaei +9 more
openaire +2 more sources
Neurology and TherapyIntroduction 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 +9 more
doaj +1 more source
The choice of gadolinium-based contrast agents: a radiologist’s responsibility between pharmaceutical equivalence and bioethical issues [PDF]
, 2017 Contrast Agents (CA) are among the most commonly prescribed drugs worldwide, and are used, with a variety of techniques, to increase and intensify the differences between body tissues and to help radiologist make diagnoses in a fast and precise way.
Cartocci, Gaia +5 more
core +2 more sources
Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis
British Journal of Clinical Pharmacology, EarlyView.Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
wiley +1 more source