Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 9 of 9 for “"Biosimilar"”.
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Eficacia y seguridad del biosimilar ABP 501 (Adalimumab) comparado con biosimilar CT-P13 (Infliximab) en pacientes adultos con artritis reumatoide. Revisión sistemática
… científica de estudios comparadores entre biosimilares, que demuestren la seguridad y eficacia, siendo esto relevante para que clínicos y aseguradores se sientan respaldados en el momento de adquirir y prescribir este tipo de moléculas. En Colombia al tratarse de una enfermedad con …
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A comprehensive guide to the three biosimilar markets (Europe, US, Japan) and the regulatory pathways
… this space to enter. Biologic generics, termed biosimilars or follow-on biologics, are more difficult to evaluate due to the complex nature of the molecule and the variables involved in the development and manufacturing process. This research seeks to understand the current debate in the …
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Heterologous production of recombinant peptidylglycine α-amidating monooxygenase for the production of biosimilar α-amidated peptides
A biological method for peptide synthesis provides increased production capacity of inexpensive peptide pharmaceuticals with environmentally safe procedures relative to current chemical peptide synthesis. Most precursor peptides are readily produced from yeast and bacterial systems using …
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Valoración de la eficacia de Infliximab biosimilar (CT-P13, remsima®) frente al Infliiximab original (Remicade®) en pacientes con enfermedad inflamatoria intestinal.
… patentes, se ha llevado a cabo el desarrollo de biosimilares de estos fármacos, con el objetivo de proporcionar importantes ahorros de costes y una mayor accesibilidad al tratamiento. En 2013, la Agencia de Medicamentos Europea (EMA) aprobó el primer biosimilar del Infliximab (CT-P13) con las …
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An Analysis of Trends of Generic Drugs and Biologic Prices in the U.S.
… for the US healthcare system. Generic and biosimilar market competition reduces drug and biologic prices, results in substantial savings, and improves patient access and outcomes. As the costs of healthcare and prescription drugs continue to rise, the discussion about drug prices has taken …
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Biosimilars: A New Look on Process Innovation and the Impact of Competitive Dynamics
… segment of the cost, governments have created biosimilar regulatory pathways in attempt to lower the costs of biologics. Biosimilars may be viewed as a “pure” or distinct type of process innovation completely separate from product innovation due to the Regulatory requirements and this novel …
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Novel Bayesian Adaptive Clinical Trial Designs In Early Phases
… Chapter 4 focuses on phase II design for biosimilar drug development. Biosimilar is a term that describes the equivalence of a generic version to an innovator's biologic drug product; biosimilars are close, but not exact copies of biologic drugs already on the market. Guidelines for …
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Using the health policy triangle framework to describe local, regional and national healthcare policy changes within Ireland's diverse healthcare settings
… teaching hospital to permit the introduction of biosimilar infliximab CT-P13, for the treatment of IBD, into routine care in a safe and timely manner. The review of this local policy decision found that there was a significant time lag of over three years between regulatory approval and clinical …
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Trends in Prices of Insulin Marketed in the US
… AWP CAGR ranging 9.5%- 9.75%. The 2 follow-on (biosimilar) insulins; long-acting insulin glargine and rapid-acting insulin lispro experienced a negative adjusted CAGR (-1.20%, -33.70%, respectively). Insulin acquisition cost and reimbursement amounts showed a large variation when compared with …