Dissertation/ Thesis
生物相似性藥品互換性之統計評估 ; Statistical Evaluation of Interchangeability of Biosimilar Drug Products
| العنوان: | 生物相似性藥品互換性之統計評估 ; Statistical Evaluation of Interchangeability of Biosimilar Drug Products |
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| المؤلفون: | 熊雅璇, Hsiung, Ya-Hsuan |
| المساهمون: | 生物資源暨農學院: 農藝學研究所, 指導教授: 劉仁沛, 熊雅璇, Hsiung, Ya-Hsuan |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | 生物製劑, 生物相似性藥品, 互換性, 個別處理效應交互作用, 交叉設計, 改良式大樣本方法, Biological product, Biosimialr product, Interchangeability, Subject-by-Formulation Interaction, Cross-over Design, Modified Large Sample Method, manag, envir |
| Time: | 85 |
| الوصف: | 生物製劑是利用生命系統或生物體所製造的藥品或醫療器材，相對於具有專利的原廠生物製劑，生物相似藥品與原廠藥品具有高度相似性，由於兩者僅在臨床非活性成分上有微小的差異，在安全性、純度與效力上，無臨床上有意義的差異。因此在原廠對照生物製劑專利期限到期後，具有相同療效與安全性但價格較低之生物相似性藥品的投入，不僅能夠造福更多的病患，更能減輕全民健保的負擔。 然而，由於生物製劑的製程過程十分複雜，即使生物相似性藥品與原廠對照生物製劑僅有些微的成分不同，也可能造成臨床上顯著的差異，或引起嚴重的過敏反應。因此生物相似性藥品，相對於原廠對照生物製劑研發規模和成本較小的情況下，必須透過統計方法，以謹慎評估生物相似性藥品之安全性、純度與效力上，是否不具有臨床上顯著的差異。 互換性為其中一評估條件，當生物相似性藥品與原廠對照生物製劑，均在同一位病人上重複施用，可分別得到生物相似性藥品及原廠對照生物製劑的反應值分布，若兩分布很接近表示生物相似性藥品與原廠對照生物製劑具有互換性。本研究即嘗試以個體與處理交互作用的變異數作為互換性指標，推導出2x4交叉設計下相對應的統計推論，以評估互換性是否成立，更進一步計算互換性評估所需樣本數，最後以實例和模擬介紹所提出方法之應用。 ; Biological products are defined as therapeutic agents or medical devices manufactured by living systems or living organisms. Because of the complexity of manufacturing process, biological products are costly. A Biosimilar product is approved if it is highly similar to a reference biological product which is under patent protection. So, after the expiration of the patent protects of the reference products, the biosimilar with the same therapeutically effect may get into the market and saves numerous patients who can only afford the less expensive biosimilar product than the reference one. However, unlike the conventional chemical drug with small molecules, the biological products are composed of complex compounds such as proteins, nucleotides. Even a minor difference in clinically inactive components may cause a serious adverse effect or death. Thus, the traditional methods in evaluation for bioequivalence of a generic drug are not appropriate for evaluating biosimilar products. Therefore, stricter statistical criteria are necessary for assessment between the biosimilar drug product and the reference product. One of the requirements for biosimilar drug products stated by the United States Food and Drug Administration is that biosimilar drug products are expected to achieve the same clinical effects in any given patient as the reference biological products. Therefore, biosimilar drug product and the reference biological product are interchangeable. Interchangeability dictates that the marginal ... |
| نوع الوثيقة: | thesis |
| اللغة: | English |
| Relation: | http://ntur.lib.ntu.edu.tw/bitstream/246246/275876/1/ntu-104-R02621206-1.pdf; http://ntur.lib.ntu.edu.tw/handle/246246/275876 |
| الاتاحة: | http://ntur.lib.ntu.edu.tw/bitstream/246246/275876/1/ntu-104-R02621206-1.pdf http://ntur.lib.ntu.edu.tw/handle/246246/275876 |
| Rights: | undefined |
| رقم الانضمام: | edsbas.B8EE4814 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |