Results 41 to 50 of about 5,574 (244)

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

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers [PDF]

, 2011
As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in ...
Huzair, Farah, Kale, Dinar
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

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

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

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

Market Access Analysis of Biologics and Small-Molecule Inhibitors for Inflammatory Bowel Disease Among US Health Insurance Policies. [PDF]

, 2019
BACKGROUND AND AIMS:Treatment pathways for ulcerative colitis (UC) and Crohn's disease (CD) are shifting to a more individualized, risk-stratified approach.
Cao, Charlie, Dulai, Parambir S, Lasch, Karen, Osterman, Mark T, Riaz, Faisal, Sandborn, William J   +5 more
core  

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
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