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.

Chemoinformatics and Bioinformatics in the Pharmaceutical Sciences brings together two very important fields in pharmaceutical sciences that have been mostly seen as diverging from each other: chemoinformatics and bioinformatics. As developing drugs is an expensive and lengthy process, technology can improve the cost, efficiency and speed at which new drugs can be discovered and tested. This book presents some of the growing advancements of technology in the field of drug development and how the computational approaches explained here can reduce the financial and experimental burden of the drug discovery process. This book will be useful to pharmaceutical science researchers and students who need basic knowledge of computational techniques relevant to their projects. Bioscientists, bioinformaticians, computational scientists, and other stakeholders from industry and academia will also find this book helpful.

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.

Advanced Drug Delivery Systems in the Management of Cancer discusses recent developments in nanomedicine and nano-based drug delivery systems used in the treatment of cancers affecting the blood, lungs, brain, and kidneys. The research presented in this book includes international collaborations in the area of novel drug delivery for the treatment of cancer. Cancer therapy remains one of the greatest challenges in modern medicine, as successful treatment requires the elimination of malignant cells that are closely related to normal cells within the body. Advanced drug delivery systems are carriers for a wide range of pharmacotherapies used in many applications, including cancer treatment. The use of such carrier systems in cancer treatment is growing rapidly as they help overcome the limitations associated with conventional drug delivery systems. Some of the conventional limitations that these advanced drug delivery systems help overcome include nonspecific targeting, systemic toxicity, poor oral bioavailability, reduced efficacy, and low therapeutic index. This book begins with a brief introduction to cancer biology. This is followed by an overview of the current landscape in pharmacotherapy for the cancer management. The need for advanced drug delivery systems in oncology and cancer treatment is established, and the systems that can be used for several specific cancers are discussed. Several chapters of the book are devoted to discussing the latest technologies and advances in nanotechnology. These include practical solutions on how to design a more effective nanocarrier for the drugs used in cancer therapeutics. Each chapter is written with the goal of informing readers about the latest advancements in drug delivery system technologies while reinforcing understanding through various detailed tables, figures, and illustrations. Advanced Drug Delivery Systems in the Management of Cancer is a valuable resource for anyone working in the fields of cancer biology and drug delivery, whether in academia, research, or industry. The book will be especially useful for researchers in drug formulation and drug delivery as well as for biological and translational researchers working in the field of cancer.

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.