دانلود کتاب جنبه های زیست تحلیلی در درمان بیولوژیکی

With the 2011 approval of Yervoy, the first monoclonal antibody therapeutic targeting immune checkpoint inhibitor CTLA-4, the selection of cancer immunotherapy as the number one scientific breakthrough of the year by Science Magazine in 2013, and with the anti-PD1 monoclonal antibody therapeutics Opdivo and Keytruda approved for an ever-expanding list of oncologic indications, biologic therapeutics have entered their “Golden Age.” This further pushes the expansion of the protein and monoclonal antibody biologics towards bispecifics, trispecifics, probody therapeutics, all kinds of conjugated proteins such as PEGylated cytokines, antibody–drug conjugates, and cell/ gene therapies. Some of the associated new challenges with these booming and more complicated biologic therapeutics are the bioanalytic test methods for pharmacokinetics, pharmacodynamics, biomarkers, and immunogenicity assessments. While there have been many dedicated white papers and regulatory guidance, as well as conferences, focusing on different aspects of bioanalytic assays, we note that to date there has been no single book dedicated to covering the broad key aspects in the bioanalytical fields. With this in mind, when Wiley reached out to us for a potential book on bioanalytical aspects of biological therapeutics, we thought we could put together a wholistic and in-depth guide that would cover most of the important topics in the field of bioanalytics.