Results 111 to 120 of about 166 (149)
Some of the next articles are maybe not open access.

Chromatographic and electrophoretic assessment of Filgrastim biosimilars in pharmaceutical formulations

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

Quality by Design applications in biosimilar pharmaceutical products

Accreditation and Quality Assurance, 2008
A 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

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

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

Biosimilars and Information Exchange in Australian Pharmaceutical Patent, Trade Secret and Data Exclusivity Arrangements

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

Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information

Naunyn-Schmiedeberg's Archives of Pharmacology
Information on biosimilars was rarely disseminated on the Pharmaceuticals and Medical Devices Agency (PMDA) website of the Japanese Regulatory Agency until the fiscal year (FY) 2022. Therefore, the PMDA website for biosimilars was created in FY 2023.
Ryosuke Kuribayashi   +1 more
exaly   +3 more sources

Response Assessment to Erythropoietin-Zeta (Epo-Alpha Biosimilar) Therapy in Low-Risk Myelodysplastic Syndromes

Journal of Clinical Medicine, 2022
Donato Mannina   +2 more
exaly  

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