کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2484578 | 1114318 | 2016 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Allometric Scaling of Therapeutic Monoclonal Antibodies Using Antigen Concentration as a Correction Factor: Application to the Human Clearance Prediction
ترجمه فارسی عنوان
مقیاس آلومتریایی آنتی بادی های مونوکلونال درمان شده با استفاده از آنتیژن غلظت به عنوان یک عامل اصلاح: کاربرد پیش بینی برداشت انسان
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کلمات کلیدی
ADCCmAbMLPNCAMonoclonal antibody - آنتی بادی مونوکلونالantibody-dependent cellular cytotoxicity - آنتی بادی-وابسته به سمیت سلولی سلولیclearance - ترخیص کالا از گمرکtumor necrosis factor α - تومور نکروز عامل αSimulations - شبیهسازی یا سیمولاسیونClinical pharmacokinetics - فارماکوکینتیک بالینیPreclinical pharmacokinetics - فارماکوکینتیک پیشکلامیVascular endothelial growth factor - فاکتور رشد اندوتلیال عروقیVascular Endothelial Growth Factor (VEGF) - فاکتور رشد اندوتلیال عروقی (VEGF)TNF-α - فاکتور نکروز توموری آلفاbrain weight - وزن مغزProteins - پروتئین ها
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
Allometric scaling has been widely used for predictions of human pharmacokinetic (PK) parameters in the development of monoclonal antibody (mAb) drugs, and some correction factors have been proposed to improve the estimations. However, classic correction factors fail to offer a complete explanation of the additional differences among species besides the body weight and, thus, lack enough power to further improve the predictions. In this study, the antigen concentration was initially set as a new correction factor to predict the human clearance (CL) of mAbs. Bevacizumab was intravenously injected into 2 animal species and humans to obtain PK data to predict human CL from the animal data. Additionally, a new approach was also validated with data from 3 other mAbs which were collected through a literature review of published work. Accordingly, allometric scaling with a correction factor of the antigen concentration generated accurate estimations of the human CL of 4 mAbs, which were superior to the results obtained by other classic scaling methods. More importantly, the proposed method also achieved good predictions of individual human CL of bevacizumab. In conclusion, the potential of this method as a powerful tool for human PK estimation of mAbs in species translation has been demonstrated.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 3, March 2016, Pages 1335-1340
Journal: Journal of Pharmaceutical Sciences - Volume 105, Issue 3, March 2016, Pages 1335-1340
نویسندگان
Lei Wang, Wei Qiang, Zeneng Cheng,