Results 61 to 70 of about 40,241 (253)

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

open access: yesBritish 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   +5 more
wiley   +1 more source

Limited Options to Manage Specialty Drug Spending [PDF]

open access: yes, 2012
Outlines rising trends in costs of and spending on specialty drugs; health plans' efforts to curb specialty drug spending, including patient cost sharing and utilization management; and efforts to integrate medical and pharmaceutical ...
Divya R. Samuel, Ha T. Tu
core  

Regulatory Science Ireland: bridging the information gap on biosimilar medicines [PDF]

open access: yes, 2016
Regulatory Science Ireland (RSI) is a voluntary network of interested parties from academia, the Health Products Regulatory Authority (HPRA), pharmaceutical and medical device industries and government agencies.
Barry, Sean P.   +6 more
core   +1 more source

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

open access: yesPLoS ONE, 2022
Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies ...
L. Druedahl   +6 more
semanticscholar   +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

open access: yesBritish 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   +5 more
wiley   +1 more source

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

open access: yes, 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

A Review on Quantitative Process Analytical Technology for Continuous Downstream Processing of Monoclonal Antibodies

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT The competition in the biopharmaceutical market is increasing due to the market entry of biosimilars and rising costs in research and development of new drugs. Hence, continuous manufacturing gained significant attention due to its potential in reducing production cycle times and costs, as well as the possibility of real‐time release testing ...
Mariana Carvalho   +4 more
wiley   +1 more source

The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland

open access: yesBioDrugs, 2022
Background Biological drugs are generally expensive and produce a continuously growing share of drug costs. Yet they are essential in the treatment of many chronic diseases.
Saana V. Luukkanen   +3 more
semanticscholar   +1 more source

Lab‐Scale Continuous Biomanufacturing: A Tool for Process Development With Adaptive Strategies for Capture and Virus Inactivation

open access: yesBiotechnology and Bioengineering, EarlyView.
Schematic representation of the continuous lab‐scale process. ABSTRACT Monoclonal antibodies (mAbs) are nowadays fundamental in treating a wide range of severe diseases, including cancer, infections, or autoimmune disorders. Due to their high specificity, potent activity, and fewer side effects compared to small molecular drugs, the market for mAbs is ...
Thomas Kruse   +5 more
wiley   +1 more source

What NMR can do in the biopharmaceutical industry [PDF]

open access: yes, 2018
LBK
Fizil, Ádám   +2 more
core   +1 more source

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