Results 51 to 60 of about 18,044 (238)

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

Monoclonal antibody biosimilars for cancer treatment

iScience
Summary: Monoclonal antibodies are important cancer medicines. The European Medicines Agency (EMA) approved 48 and the Food and Drug Administration (FDA) 56 anticancer monoclonal antibody-based therapies.
Linda N. Broer, Daan G. Knapen, Derk-Jan A. de Groot, Peter G.M. Mol, Jos G.W. Kosterink, Elisabeth G.E. de Vries, Marjolijn N. Lub-de Hooge   +6 more
doaj   +1 more source

Safety of switching between rituximab biosimilars in onco-hematology

Scientific Reports, 2021
Comparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between ...
Silvana A. M. Urru, Stefania Spila Alegiani, Anna Guella, Giuseppe Traversa, Annalisa Campomori   +4 more
doaj   +1 more source

Author Correction to: Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy [PDF]

, 2017
Unfortunately, many errors were identified in the published article.
Adamo, V. (Vincenzo), Altavilla, G. (Giuseppe), Ferraù, F. (Francesco), Franchina, T. (Tindara), Intelisano, R. (Rosanna), Lucchesi, S. (Simona), Marcianò, I. (Ilaria), Panagia, P. (Paolo), Randazzo, M.P. (Maria Pia), Reitano, P. (Paolina), Santarpia, M. (Mariacarmela), Sgroi, C. (Carmela), Trifirò, G. (Gianluca)   +12 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

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

, 2016
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
core   +2 more sources

Bioethical issues in the development of biopharmaceuticals [PDF]

, 2012
Development of biopharmaceuticals is a challenging issue in bioethics. Unlike conventional, small molecular weight drugs, biopharmaceuticals are proteins derived from DNA technology and hybrid techniques with complex three dimensional structures ...
Protić Dragana, Todorović Zoran
core   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn's disease across Germany.

PLoS ONE, 2017
ObjectivesThis study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars.MethodsData were taken from the Adelphi ...
Emma Sullivan, James Piercy, John Waller, Christopher M Black, Sumesh Kachroo   +4 more
doaj   +1 more source

Policies for biosimilar uptake in Europe: An overview.

PLoS ONE, 2017
BackgroundAcross European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.ObjectivesThe aim of this article is to provide an overview of different initiatives ...
Evelien Moorkens, Arnold G Vulto, Isabelle Huys, Pieter Dylst, Brian Godman, Simon Keuerleber, Barbara Claus, Maria Dimitrova, Guenka Petrova, Ljiljana Sović-Brkičić, Juraj Slabý, Robin Šebesta, Ott Laius, Allan Karr, Morgane Beck, Jaana E Martikainen, Gisbert W Selke, Susan Spillane, Laura McCullagh, Gianluca Trifirò, Patricia Vella Bonanno, Asbjørn Mack, Antra Fogele, Anita Viksna, Magdalena Władysiuk, Helder Mota-Filipe, Dmitry Meshkov, Marija Kalaba, Simona Mencej Bedrač, Jurij Fürst, Corrine Zara, Peter Skiöld, Einar Magnússon, Steven Simoens   +33 more
doaj   +1 more source