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Physicochemical and Biological Characterization of a Biosimilar Trastuzumab
المؤلفون المشاركون
López-Morales, Carlos A.
Miranda-Hernández, Mariana P.
Juárez-Bayardo, L. Carmina
Ramírez-Ibáñez, Nancy D.
Piña-Lara, Nelly
Campos-García, Víctor R.
Romero-Díaz, Alexis J.
Pérez, Néstor O.
Medina-Rivero, Emilio
Flores-Ortiz, Luis F.
المصدر
العدد
المجلد 2015، العدد 2015 (31 ديسمبر/كانون الأول 2015)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2015-05-17
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص EN
According to the World Health Organization, the incidence of malignant neoplasms and endocrine, blood, and immune disorders will increase in the upcoming decades along with the demand of affordable treatments.
In response to this need, the development of biosimilar drugs is increasing worldwide.
The approval of biosimilars relies on the compliance with international guidelines, starting with the demonstration of similarity in their physicochemical and functional properties against the reference product.
Subsequent clinical studies are performed to demonstrate similar pharmacological behavior and to diminish the uncertainty related to their safety and efficacy.
Herein we present a comparability exercise between a biosimilar trastuzumab and its reference product, by using a hierarchical strategy with an orthogonal approach, to assess the physicochemical and biological attributes with potential impact on its pharmacokinetics, pharmacodynamics, and immunogenicity.
Our results showed that the high degree of similarity in the physicochemical attributes of the biosimilar trastuzumab with respect to the reference product resulted in comparable biological activity, demonstrating that a controlled process is able to provide consistently the expected product.
These results also constitute the basis for the design of subsequent delimited pharmacological studies, as they diminish the uncertainty of exhibiting different profiles.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
López-Morales, Carlos A.& Miranda-Hernández, Mariana P.& Juárez-Bayardo, L. Carmina& Ramírez-Ibáñez, Nancy D.& Romero-Díaz, Alexis J.& Piña-Lara, Nelly…[et al.]. 2015. Physicochemical and Biological Characterization of a Biosimilar Trastuzumab. BioMed Research International،Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1055450
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
López-Morales, Carlos A.…[et al.]. Physicochemical and Biological Characterization of a Biosimilar Trastuzumab. BioMed Research International No. 2015 (2015), pp.1-10.
https://search.emarefa.net/detail/BIM-1055450
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
López-Morales, Carlos A.& Miranda-Hernández, Mariana P.& Juárez-Bayardo, L. Carmina& Ramírez-Ibáñez, Nancy D.& Romero-Díaz, Alexis J.& Piña-Lara, Nelly…[et al.]. Physicochemical and Biological Characterization of a Biosimilar Trastuzumab. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1055450
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1055450
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر
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