Results 41 to 50 of about 5,542 (243)

QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda®

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, Farzad Khanipour, Amir Maghsoudi, Rahim Sarvestani, Mahdi Mohammadian, Maryam Maleki, Forugh Havasi, Hossein Rahmani, Amir-Hossein Karagah, Mohammad-Reza Kazemali   +9 more
openaire   +2 more sources

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

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

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

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

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

Outcome-based pricing for new pharmaceuticals via rebates [PDF]

, 2020
The price of new brand-name prescription drugs has been rising fast in the United States. For example, the Amgen cholesterol drug Repatha had an initial list price of $14,523 per year.
Adida, E
core  

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

Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland [PDF]

, 2017
Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in ...
Bermingham, Margaret, Griffin, Brendan T., Hallinan, Frank, Leonard, Maurice, Moore, Una, Morris, J. Michael, O'Callaghan, Joan   +6 more
core   +1 more source