Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization.

"Principles of Clinical Pharmacology" is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the third edition has been thoroughly updated to provide readers with an ideal reference covering the wide range of important topics impacting clinical pharmacology as the discipline plays an increasingly significant role in drug development and regulatory science.

The Third Edition has been endorsed by the American Society for Clinical Pharmacology and Therapeutics

* Includes new chapters on imaging and the pharmacogenetic basis of adverse drug reactions. * Offers an expanded regulatory section that addresses US and international issues and guidelines. * Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers and also illustrates the impact of gender on drug response. * Presents a broadened discussion of clinical trials from Phase 1 to incorporate Phases II and III.

Dendrimer-Based Nanotherapeutics delivers a comprehensive resource on the use of dendrimer-based drug delivery. Advances in the application of nanotechnology in medicine have given rise to multifunctional smart nanocarriers that can be engineered with tunable physicochemical characteristics to deliver one or more therapeutic agent(s) safely and selectively to cancer cells, including intracellular organelle-specific targeting. This book compiles the contribution of dendrimers in the field of nanotechnology to aid researchers in exploring dendrimers in the field of drug delivery and related applications. This book covers the history of the area to the most recent research. The starting chapter covers detailed information about basic properties about dendrimers i.e. properties, nomenclature, synthesis methods, types, characterization of dendrimers, safety and toxicity issues of dendrimers. Further chapters discuss the most recent advancements in the field of dendrimer i.e. dendrimer-drug conjugates, PEGylated dendrimer, dendrimer surface engineering, dendrimer hybrids, dendrimers as solubility enhancement, in targeting and delivery of drugs, as photodynamic therapy, in tissue engineering, as imaging contrast agents, as antimicrobial agents, advances in targeted dendrimers for cancer therapy and future considerations of dendrimers. Dendrimer-Based Nanotherapeutics will help the readers to understand the most recent progress in the field of dendrimer-based research, suitable for pharmaceutical scientists, advanced students, and those working in related healthcare fields.

Engineering Technologies and Clinical Translation: Volume 3: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy examines the challenges of delivering immuno-oncology therapies, focusing specifically on the development of solutions for drug delivery and its clinical outcomes. Immuno-oncology (IO) is a growing field of medicine at the interface of immunology and cancer biology leading to development of novel therapeutic approaches, such as chimeric antigen receptor T-cell (CAR-T) and immune checkpoint blockade antibodies, that are clinically approved approaches for cancer therapy. Although currently approved IO approaches have shown tremendous promise for select types of cancers, broad application of IO strategies could even further improve the clinical success, especially for diseases such as pancreatic cancer, brain tumors where the success of IO so far has been limited. This volume of Delivery Strategies and Engineering Technologies in Cancer Immunotherapy discusses biomaterial, microfluidic, and biodegradable devices, engineered microbes, personalized medicine, clinical approval process, and many other IO technologies. Engineering Technologies and Clinical Translation: Volume 3: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy creates a comprehensive treaty that engages the scientific and medical community who are involved in the challenges of immunology, cancer biology, and therapeutics with possible solutions from the nanotechnology and drug delivery side.

Direct Nose-to-Brain Drug Delivery provides the reader with precise knowledge about the strategies and approaches for enhanced nose-to-brain drug delivery. It highlights the development of novel nanocarrier-based drug delivery systems for targeted drug delivery to the brain microenvironments with a focus on the technological advances in the development of the novel drug delivery devices for intranasal administration, including special emphasis on brain targeting through nose. This book explores the various quantification parameters to assess the brain targeting efficiency following intranasal administration and includes an overview on the toxicity aspects of the various materials used to develop the direct nose-to-brain drug delivery vehicles and of the regulatory aspects including patents and current clinical status of the potential neurotherapeutics for the effective management of neuro-ailments. Technological advances in new drug delivery systems with diverse applications in pharmaceutical, biomedical, biomaterials, and biotechnological fields are also explained. This book is a crucial source that will assist the veteran scientists, industrial technologists, and clinical research professionals to develop new drug delivery systems and novel drug administration devices for the treatment of neuro-ailments.

Reliable, precise and accurate detection and analysis of biomarkers remains a significant challenge for clinical researchers. Methods for the detection of biomarkers are rather complex, requiring pre-treatment steps before analysis can take place. Moreover, comparing various biomarker assays and tracing research progress in this area systematically is a challenge for researchers. The Detection of Biomarkers presents developments in biomarker detection, including methods tools and strategies, biosensor design, materials, and applications. The book presents methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical, and therefore highly practical for use in clinical research scenarios. This volume situates biomarker detection in its research context and sets out future prospects for the area. Its 20 chapters offer a comprehensive coverage of biomarkers, including progress on nanotechnology, biosensor types, synthesis, immobilization, and applications in various fields. The book also demonstrates, for students, how to synthesize and immobilize biosensors for biomarker assay. It offers researchers real alternative and innovative ways to think about the field of biomarker detection, increasing the reliability, precision and accuracy of biomarker detection.

Brucella Miletensis: Identification and Characterization of Potential Drug Targets presents a systematic approach to identifying and characterizing drug targets using bioinformatics. The book shows the potential of bioinformatic tools in the identification of virulence targets in pathogenic bacteria and viruses, in general, and in B. militensis 16M in particular. Chapters identify putative genes as potential drug targets, employ a subtractive genomic approach, consider the virulent genes of this bacteria that negatively affects humans, list twelve potential virulence genes as drug targets, and consider the screening of potential drugs against the bacteria's virulence genes through molecular modeling, computational screening, drug discovery and molecular docking studies. In addition, the book demonstrates in silico approaches that offer insights into the identification of drug targets in B.melitensis 16M. The title employs a step-by-step approach to understanding drug targets by identifying and characterizing vaccine targets for Brucella melitensis, in silico screening, and the identification of novel drug targets from the total Brucella melitensis proteome. Other sections cover computational modeling and evaluation of the best potential drug targets through comparative modeling, molecular docking, and dynamics simulations of novel drug targets and in silico validation and ADMET analysis for best lead molecules.