Results 201 to 210 of about 5,542 (243)
State Substitution Laws and Uptake of an Interchangeable Insulin Biosimilar.
JAMA Health ForumKwon Y, Sarpatwari A, Dusetzina SB.
europepmc +1 more source
Risk management in the distribution process of biosimilar products in the pharmaceutical industry
, 2016 openaire +1 more source
Some of the next articles are maybe not open access.
Related searches:
Related searches:
Journal of Oncology Pharmacy Practice, 2021
Objective To evaluate the safety in the interchangeability of biosimilar products approved for cancer treatment from a pharmaceutical perspective. Methods A literature review was carried out using the descriptors “Biosimilar”, “Oncology Therapy”, “Interchangeable drugs” and “Biological Products”, in the Sciencedirect, MEDLINE, and CAPLUS databases ...
José Cleberson Santos Soares +2 more
openaire +2 more sources
Objective To evaluate the safety in the interchangeability of biosimilar products approved for cancer treatment from a pharmaceutical perspective. Methods A literature review was carried out using the descriptors “Biosimilar”, “Oncology Therapy”, “Interchangeable drugs” and “Biological Products”, in the Sciencedirect, MEDLINE, and CAPLUS databases ...
José Cleberson Santos Soares +2 more
openaire +2 more sources
Addressing the health technology assessment of biosimilar pharmaceuticals
Current Medical Research and Opinion, 2010Abstract The growing number of biosimilars presents challenges to regulatory and health technology assessment (HTA) systems. This paper illustrates these challenges by focusing on biosimilars used in the oncological setting. In particular, discordances between data required by regulatory and HTA authorities potentially deprive patients of effective ...
Alan, Stewart +2 more
openaire +2 more sources
Quality by Design applications in biosimilar pharmaceutical products
Accreditation and Quality Assurance, 2008A process is well understood when all critical sources of variability are identified and explained, variability is managed by the process design and monitoring, and product quality attributes are accurately and reliably predicted over the design space.
Ron S. Kenett, Dan A. Kenett
openaire +1 more source
Journal of Pharmaceutical and Biomedical Analysis, 2014
An orthogonal testing protocol was developed and validated to assess the quality of Filgrastim biosimilars. Results were compared to those obtained from the innovator product. Initial screening was carried out using reducing and non-reducing gel electrophoresis.
Eman L, Shaltout +3 more
openaire +2 more sources
An orthogonal testing protocol was developed and validated to assess the quality of Filgrastim biosimilars. Results were compared to those obtained from the innovator product. Initial screening was carried out using reducing and non-reducing gel electrophoresis.
Eman L, Shaltout +3 more
openaire +2 more sources
Bioanalysis, 2013
Due to their versatility and cost-effectiveness, gel electrophoretic methods provide an important set of tools for the analysis of therapeutic proteins. As an increasing number of biosimilar pharmaceuticals are entering the market, techniques are required that allow reliable demonstration of comparability of these products with the reference products ...
Christian, Reichel, Mario, Thevis
openaire +2 more sources
Due to their versatility and cost-effectiveness, gel electrophoretic methods provide an important set of tools for the analysis of therapeutic proteins. As an increasing number of biosimilar pharmaceuticals are entering the market, techniques are required that allow reliable demonstration of comparability of these products with the reference products ...
Christian, Reichel, Mario, Thevis
openaire +2 more sources
Generics and Biosimilars Initiative Journal, 2021
At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic.
Esteban Ortiz-Prado +5 more
openaire +1 more source
At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic.
Esteban Ortiz-Prado +5 more
openaire +1 more source
2022
More specifically, this thesis examines the information exchange between originator manufacturers and biosimilar manufacturers related to patents and data exclusivity, and how the information exchange affects biosimilars and biosimilar development.
openaire +1 more source
More specifically, this thesis examines the information exchange between originator manufacturers and biosimilar manufacturers related to patents and data exclusivity, and how the information exchange affects biosimilars and biosimilar development.
openaire +1 more source