Results 41 to 50 of about 681,456 (227)

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

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

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

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

Fostering medication review competence of pharmacy students: An assessment by students and their preceptors after advanced‐level practical internship

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study was to introduce a new assessment method for pharmacy students' real‐life competence in reviewing medications after obligatory advanced‐level practical internship in Finland. Methods The new medication review (MR) competence assessment method consisted of (1) a self‐assessment by pharmacy students and (2) a performance ...
Katja Leiman, Aleksi Westerholm, Tero Vahlberg, Noora Lias, Tanja Lindholm, Marja Airaksinen   +5 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

Cost effectiveness of using trastuzumab biosimilars compared to trastuzumab original drugs to treat breast cancer in a hospital setting

Breast, 2023
Introduction: Subcutaneous (SC) drug administration, such as the Herceptin® in an oncology day hospital reduces the administration time of trastuzumab.
Eric C. Barat, Marianne L.E. Arrii, Annaelle Soubieux-Bourbon, Mikaël Daouphars, Rémi Varin, Patrick R. Tilleul   +5 more
doaj   +1 more source

DISCONTINUATION RATES FOLLOWING A SWITCH FROM A REFERENCE TO A BIOSIMILAR BIOLOGIC IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS [PDF]

Arquivos de Gastroenterologia, 2020
BACKGROUND: Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars.
Natália Sousa Freitas QUEIROZ, Rogerio SAAD-HOSSNE, Renata de Sá Brito FRÓES, Francisco Guilherme Cancela e PENNA, Stefania Burjack GABRIEL, Adalberta Lima MARTINS, Fabio Vieira TEIXEIRA   +6 more
doaj   +1 more source

Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry [PDF]

DARU Journal of Pharmaceutical Sciences, 2012
In 1980s, medicines produced through recombinant DNA technology created a novel opportunity for management of several debilitating and life threatening diseases. However, these medicines are very expensive and therefore not affordable for many patients especially those living in low resourced countries.
openaire   +2 more sources

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source