Early Implementation of QbD in Biopharmaceutical Development: A Practical Example
المؤلفون المشاركون
Zurdo, Jesús
Arnell, Andreas
Obrezanova, Olga
Smith, Noel
Gómez de la Cuesta, Ramón
Gallagher, Thomas R. A.
Michael, Rebecca
Stallwood, Yvette
Ekblad, Caroline
Abrahmsén, Lars
Höidén-Guthenberg, Ingmarie
المصدر
العدد
المجلد 2015، العدد 2015 (31 ديسمبر/كانون الأول 2015)، ص ص. 1-19، 19ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2015-05-17
دولة النشر
مصر
عدد الصفحات
19
التخصصات الرئيسية
الملخص EN
In drug development, the “onus” of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or “binding” functionality).
Here, we show that manufacturing is not only a central component of product success, but also that, by integrating manufacturing and discovery activities in a “holistic” interpretation of QbD methodologies, we could expect to increase the efficiency of the drug discovery process as a whole.
In this new context, early risk assessment, using developability methodologies and computational methods in particular, can assist in reducing risks during development in a cost-effective way.
We define specific areas of risk and how they can impact product quality in a broad sense, including essential aspects such as product efficacy and patient safety.
Emerging industry practices around developability are introduced, including some specific examples of applications to biotherapeutics.
Furthermore, we suggest some potential workflows to illustrate how developability strategies can be introduced in practical terms during early drug development in order to mitigate risks, reduce drug attrition and ultimately increase the robustness of the biopharmaceutical supply chain.
Finally, we also discuss how the implementation of such methodologies could accelerate the access of new therapeutic treatments to patients in the clinic.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Zurdo, Jesús& Arnell, Andreas& Obrezanova, Olga& Smith, Noel& Gómez de la Cuesta, Ramón& Gallagher, Thomas R. A.…[et al.]. 2015. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. BioMed Research International،Vol. 2015, no. 2015, pp.1-19.
https://search.emarefa.net/detail/BIM-1056097
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Zurdo, Jesús…[et al.]. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. BioMed Research International No. 2015 (2015), pp.1-19.
https://search.emarefa.net/detail/BIM-1056097
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Zurdo, Jesús& Arnell, Andreas& Obrezanova, Olga& Smith, Noel& Gómez de la Cuesta, Ramón& Gallagher, Thomas R. A.…[et al.]. Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-19.
https://search.emarefa.net/detail/BIM-1056097
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1056097
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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