Keyword

reference products

Description: Existing products used as benchmarks or sources of design information in product development and procurement contexts.

Primary topic: Biosimilars and Bioanalytical Methods (51%)

OpenAlex ID: keywords/reference-products

Interchangeability of Biosimilars: A European Perspective

2017 · Pekka Kurki, Leon van Aerts, et al. · BioDrugs · 189

2017 · Carol F. Kirchhoff, Xiao‐Zhuo Michelle Wang, et al. · Biotechnology and Bioengineering · 179

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The role of biosimilars in the treatment of rheumatic diseases

2012 · Thomas Dörner, Vibeke Strand, et al. · Annals of the Rheumatic Diseases · 178

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Beyond the throwaway society: A life cycle-based assessment of the environmental benefit of reuse

2014 · Valentina Castellani, Serenella Sala, et al. · Integrated Environmental Assessment and Management · 167

International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

2013 · Barbara Davit, April C. Braddy, et al. · The AAPS Journal · 119

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Interchangeability, immunogenicity and biosimilars

2012 · Hans C Ebbers, Stacy A Crow, et al. · Nature Biotechnology · 99

Product Profiles: Modelling customer benefits as a foundation to bring inventions to innovations

2018 · Albert Albers, Jonas Heimicke, et al. · Procedia CIRP · 81

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The Reference System in the Model of PGE: Proposing a Generalized Description of Reference Products and their Interrelations

2019 · Albert Albers, Simon Rapp, et al. · Proceedings of the ... International Conference on Engineering Design · 80

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2015 · Lilian Rumi Tsuruta, Mariana Lopes dos Santos, et al. · Biotechnology Progress · 74

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Development of biosimilars

2016 · Ahmad AL-Sabbagh, Ewa Olech, et al. · Seminars in Arthritis and Rheumatism · 70

Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial

2020 · Marie-Christine Bielsky, Anne Cook, et al. · Drug Discovery Today · 62

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International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

2015 · Dongmei Lu, Sau L. Lee, et al. · The AAPS Journal · 58

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Produktgenerationsentwicklung - Bedeutung und Herausforderungen aus einer entwicklungsmethodischen Perspektive

2015 · Albert Albers, Nikola Bursac, et al. · tub.dok (Hamburg University of Technology) · 58

Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada

2013 · Upendra C. Galgatte, Vijay R. Jamdade, et al. · Saudi Pharmaceutical Journal · 54

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Regulatory challenges with biosimilars: an update from 20 countries

2020 · Hye‐Na Kang, Robin Thorpe, et al. · Annals of the New York Academy of Sciences · 52

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How Much Are Biosimilars Used in Clinical Practice? A Retrospective Italian Population-Based Study of Erythropoiesis-Stimulating Agents in the Years 2009–2013

2015 · Ylenia Ingrasciotta, Francesco Giorgianni, et al. · BioDrugs · 52

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Biosimilars: Extrapolation for oncology

2016 · Giuseppe Curigliano, Darran P. O’Connor, et al. · Critical Reviews in Oncology/Hematology · 48

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Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products

2020 · Thomas J. Moore, Morgane C. Mouslim, et al. · JAMA Internal Medicine · 47

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Comparative Effectiveness of Biosimilar, Reference Product and Other Erythropoiesis-Stimulating Agents (ESAs) Still Covered by Patent in Chronic Kidney Disease and Cancer Patients: An Italian Population-Based Study

2016 · Ylenia Ingrasciotta, Francesco Giorgianni, et al. · PLoS ONE · 41

Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products

2017 · Ohseok Kwon, Jeewon Joung, et al. · Biologicals · 39

Agile product engineering through continuous validation in PGE – Product Generation Engineering

2017 · Albert Albers, Matthias Behrendt, et al. · Design Science · 35

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Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans

2020 · James D. Chambers, Rachel C. Lai, et al. · JAMA · 33

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PGE – Produktgenerationsentwicklung am Beispiel des Zweimassenschwungrads

2016 · Albert Albers, Nikola Bursac, et al. · Forschung im Ingenieurwesen · 33

Differentiating biosimilarity and comparability in biotherapeutics

2016 · Valderilio Azevedo, Brian Hassett, et al. · Clinical Rheumatology · 33

Discriminations of the A–Not A difference test improved when “A” was familiarized using a brand image

2011 · Min-A Kim, Ji-Eun Chae, et al. · Food Quality and Preference · 33

Works count: 346

Citation count: 3,237