خرید کتاب از گوگل

چاپ کتاب PDF,

خرید کتاب از آمازون,

خرید کتاب زبان اصلی,

دانلود کتاب خارجی,

دانلود کتاب لاتین

برای ثبت درخواست به انتهای صفحه مراجعه کنید.

Development of Antibody-Based Therapeutics

Translational Considerations & Challenges

Description:... The biologics market continues to witness an impressive rate of growth and the monoclonal antibody market, in particular, has contributed remarkably to the expansion of this segment within the pharmaceutical industry. In 2006, close to 80% of the annual biologics growth rate in the United States (US) was attributed to cancer and anti-TNF antibodies, with increases in growth of 56% and 25%, respectively, compared to those in the previous year. Additionally, the monoclonal antibody sector is anticipated to achieve a growth rate of approximately 14% by 2012, easily outstripping the predicted 0.6% growth rate in the small molecules market. The robust late-stage antibody pipeline within the biotech sector has drawn an increasing amount of interest from the large pharmaceutical industry and has triggered the largest product and platform deals in 2006, with values more than $2.1 and $5.1 billion in partnering and mergers and acquisitions, respectively. Additionally, with the forthcoming emergence of biogenerics, next-generation bio-improved antibodies have drawn much attention and increasingly contribute to the growth of the biologics segment. As next-generation monoclonal antibodies confront their first-generation rivals, it is critical that these next-generation products offer a clear differentiating advantage against the existing competition. Successful strategies for the development of monoclonal antibodies require integration of knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, Fc domain engineering, pharmacokinetic and pharmacodynamic (PK/PD) properties, antibody cross-reactivity across species, market differentiation opportunities for the first- and next-generation leads, and regulatory requirements from the early stages of antibody development. Biophysical measurements are one of the critical components necessary for the design of effective translational strategies for lead selection and evaluation of relevant animal species for preclinical safety and efficacy studies. Incorporation of effective translational strategies from the early stages of the antibody development process is a necessity, and when considered, it not only reduces development time and cost, but also fosters implementation of rational decision-making throughout all phases of antibody development. Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the ‘unit dose’ and ‘unit effect’ with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective and novel next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in “relevant” animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of bio-improved antibody candidates for market entry. This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.

Show description

* ایمیل (آدرس Email را با دقت وارد کنید)
لینک پیگیری درخواست ایمیل می شود.
شماره تماس (ارسال لینک پیگیری از طریق SMS)
نمونه: 09123456789

در صورت نیاز توضیحات تکمیلی درخواست خود را وارد کنید

* تصویر امنیتی
 

به شما اطمینان می دهیم در کمتر از 8 ساعت به درخواست شما پاسخ خواهیم داد.

* نتیجه بررسی از طریق ایمیل ارسال خواهد شد

کتاب زبان اصلی J.R.R
کتاب انگلیسی-
کیندل چیست-
درخواست کتاب خارجی-
خرید کتاب آمازون-
خرید کتاب فیزیکی از آمازون-
سفارش کتاب خارجی-
مجله نیوانگلند-
درخواست کتاب از آمازون-
دانلود فایل های زبان اصلی شیمی تحلیلی-
سایت خرید کتاب های خارجی
ضمانت بازگشت وجه بدون شرط
اعتماد سازی
انتقال وجه کارت به کارت
X

پرداخت وجه کارت به کارت

شماره کارت : 6104337650971516
شماره حساب : 8228146163
شناسه شبا (انتقال پایا) : IR410120020000008228146163
بانک ملت به نام مهدی تاج دینی

پس از پرداخت به صورت کارت به کارت، 4 رقم آخر شماره کارت خود را برای ما ارسال کنید.
X