Tailor-Made Polysaccharides in Drug Delivery provides extensive details on all the vital precepts, basics and fundamental aspects of tailored polysaccharides in the pharmaceutical and biotechnological industry for understanding and developing high quality products. The book offers a comprehensive resource to understand the potential of the materials in forming new drug delivery methods. It will be useful to pharmaceutical scientists, chemical engineers, and regulatory scientists and students actively involved in pharmaceutical product and process development of tailored-made polysaccharides in drug delivery applications. The utilization of natural polymeric excipients in numerous healthcare applications demand the replacement of the synthetic polymers with the natural ones due to their biocompatibility, biodegradability, economic extraction and readily availability. The reality behind the rise in importance of these natural materials is that these sources are renewable if grown in a sustainable means and they can tender incessant supply of raw materials. Amongst these natural polymers, polysaccharides are considered as excellent excipients because of its non-toxic, stable, biodegradable properties. Several research innovations have been made on applications of polysaccharides in drug delivery.

Oral Delivery of Therapeutic Peptides and Proteins provides a complete overview of the journey scientists pursue to attain protein and peptide oral delivery. The book highlights the physiological challenges that must be accounted for in addition to overcoming protease inhibition and acid stability issues that are commonly mentioned in this area of research. Primary topics include formulation technologies being adopted for oral delivery of proteins and peptides, modification of actives to make them more suited for oral delivery, animal models and their shortcomings in assessing oral bioavailability, and in vitro models to simulate drug absorption and transport. Academics and industry researchers working in formulation development and researchers and advanced students in biotechnology and pharmacy will find this a useful resource.

Stimuli-Responsive Nanocarriers: Recent Advances in Tailor-Made Therapeutics compiles dispersed knowledge into a complete and comprehensive source to help researchers understand and progress stimuli-responsive nanocarriers. The book contains recent advancements made in the field of stimuli-responsive nanocarriers with their application in controlled drug delivery against various diseases. It focuses on the design, mechanism, construction, therapeutic application and future challenges of stimuli-responsive nanocarriers which will help new researchers in designing next generation tailor-made advanced therapeutics. Finally, the book covers future aspects and challenges present in the route of development of stimuli responsive nanocarriers for disease therapeutics. Various recent advances and biomedical applications assembled in this book will guide scientists on how to design and develop novel controlled drug release systems.

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.

Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists.

Bioinspired and Biomimetic Materials for Drug Delivery delves into the potential of bioinspired materials in drug delivery, detailing each material type and its latest developments. In the last decade, biomimetic and bioinspired materials and technology has garnered increased attention in drug delivery research. Various material types including polymer, small molecular, protein, peptide, cholesterol, polysaccharide, nano-crystal and hybrid materials are widely considered in drug delivery research. However, biomimetic and bioinspired materials and technology have shown promising results for use in therapeutics, due to their high biocompatibility and reduced immunogenicity. Such materials include dopamine, extracellular exosome, bile acids, ionic liquids, and red blood cell. This book covers each of these materials in detail, reviewing their potential and usage in drug delivery. As such, this book will be a great source of information for biomaterials scientists, biomedical engineers and those working in pharmaceutical research.

Herbal Biomolecules in Healthcare Applications presents extensive detailed information on all the vital principles, basics and fundamental aspects of multiple herbal biomolecules in the healthcare industry. This book examines important herbal biomolecules including alkaloids, glycosides, flavonoids, anthraquinones, steroids, polysaccharides, tannins and polyphenolic compounds, terpenes, fats and waxes, proteins and peptides, and vitamins. These herbal biomacromolecules are responsible for different bioactivities as well as pharmacological potentials. A systematic understanding of the extraction, purification, characterization, applications of these herbal biomolecules and their derivatives in healthcare fields is developed in this comprehensive book. Chapters explore the key topics along with an emphasis on recent research and developments in healthcare fields by leading experts. They include updated literature review of the relevant key topics, good quality illustrations, chemical structures, flow charts, well-organized tables and case studies. Herbal Biomolecules in Healthcare Applications will be useful for researchers working on natural products and biomolecules with bioactivity and nutraceutical properties. Professionals specializing in scientific areas such as biochemistry, pharmacology, analytical chemistry, organic chemistry, clinics, or engineering focused on bioactive natural products will find this book useful.

Pharmaceuticals in Marine and Coastal Environments: Occurrence, Effects, and Challenges in a Changing World is divided into three sections that address a) coastal areas as the main entrance of pharmaceuticals into the ocean, b) the occurrence and distribution of pharmaceuticals in the environmental compartments of the ocean media, and c) the effects that such pollutants may cause to the exposed marine organisms. With its comprehensive discussions, the book provides a wide depiction of the current state-of-the-art on these topics in an effort to open new sources of investigation and find suitable solutions.

Phytochemical Profiling of Commercially Important South African Plants comprises a carefully selected group of plant species that are of interest to researchers and industry partners who would like to investigate the commercialization of plant species. The book presents 25 botanicals selected based on commercial relevance. For each of the species, the following topics are covered: botanical description and distribution, phytochemistry (including chemical structures), HPTLC fingerprint analysis, UPLC analysis, and GC analysis (the latter only in the case of essential oil-bearing species). Using standard methodology, high-level chromatographic fingerprints have been developed for better understanding. Different methods are succinctly summarized allowing for the rapid identification of botanical raw materials and formulated consumer products. This book will be extremely valuable to researchers in the field who wish to rapidly identify the constituents and for those who want to prepare formulations of plant material for commercial applications. This work will also be a valuable resource in the field of pharmacognosy.

Pharmacy Practice Research Case Studies provides examples and details regarding how pharmacy practice research has transformed over the past decade and how this is impacting overall health. This book presents several methodologies and techniques used in current pharmacy practice. According to the United Nations Sustainable Development Goals, countries around the world are aiming to achieve Universal Health Coverage. In this context, pharmacists are a vital part of the healthcare teams and the book portrays the research methods used in conducting pharmacy practice and medicines use research. The professional role of pharmacists has evolved tremendously over the past few decades across the globe and the pace of change has been interestingly phenomenal in varying aspects. The book provides a great resource for pharmacists, pharmaceutical scientists, policymakers, and researchers to understand the dimensions of practice, education, research, and policy concerning pharmacy, and it provides the synthesis of the development so far, pointing to the needs and demands of the future.

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.

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.

A Mechanistic Approach to Medicines for Tuberculosis Nanotherapy examines drug carrier development for controlled, targeted, pH and stimuli responsive drug releases for tuberculosis. The book provides in-depth information about mycobacterium tuberculosis, tuberculosis formation, and synthetic procedures for carrier synthesis, characterizations and mechanistic approaches. Key topics include the properties and functions of nanomedicines and how they might be applied for clinical diagnosis and treatment. Emphasis is placed on the basic fundamentals, biomaterial formulations, design principles, fabrication techniques, and transitioning bench-to-bed clinical applications. This book is useful for new researchers who focus on nanomedicine, stem cell therapy and bone tissue engineering. In addition, it introduces experienced researchers and clinicians to key trends, thus increasing their knowledge in drug discovery for tuberculosis and nanomedicine.

Theory and Applications of Nonparenteral Nanomedicines presents thoroughly analysed data and results regarding the potential of nanomedicines conceived by diverse non-parenteral routes. In the context of nanotechnology-based approaches, various routes such as oral, pulmonary, transdermal, delivery and local administration of nanomedicine have been utilized for the delivery of nanomedicine. This book discusses the non-parenteral application of nanomedicine, its regulatory implications, application of mucus penetrating nanocarrier, and detailed chapters on development of nanomedicines developed for drug delivery by various route. Beginning with a brief introduction to the non-parenteral delivery of nanomedicine and the safety and regulatory implications of the nanoformulations, further chapters discuss the physiology of the biological barriers, the specificity of the nanocarriers as well as their multiple applications. Theory and Applications of Nonparenteral Nanomedicines helps clinical researchers, researchers working in pharmaceutical industries, graduate students, and anyone working in the development of non-parenteral nanomedicines to understand the recent progress in the design and development of nanoformulations compatible with non-parenteral applications.

Drug Delivery Devices and Therapeutic Systems examines the current technology and innovations moving drug delivery systems (DDS) forward. The book provides an overview on the therapeutic use of drug delivery devices, including design, applications, and a description of the design of each device. While other books focus on the therapy, the primary emphasis in this book is on current technologies for DDS applications, including microfluidics, nanotechnology, biodegradable hydrogel and microneedles, with a special emphasis on wearable DDS. As part of the Developments in Biomedical Engineering and Bioelectronics series, this book is written by experts in the field and informed with information directly from manufacturers. Pharmaceutical scientists, medical researchers, biomedical engineers and clinical professionals will find this an essential reference.

Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.

Preparation of Phytopharmaceuticals for the Management of Disorders: The Development of Nutraceuticals and Traditional Medicine presents comprehensive coverage and recent advances surrounding phytopharmaceuticals, nutraceuticals and traditional and alternative systems of medicines. Sections cover the concepts of phytopharmaceuticals, their history, and current highlights in phytomedicine. Also included are classifications of crude drugs, herbal remedies and toxicity, traditional and alternative systems of medicine, nanotechnology applications, and herbal cosmeticology. Final sections cover applications of microbiology and biotechnology in drug discovery. This book provides key information for everyone interested in drug discovery, including medicinal chemists, nutritionists, biochemists, toxicologists, drug developers and health care professionals. Students, professors and researchers working in the area of pharmaceutical sciences and beyond will also find the book useful.

Nanotechnology for Oral Drug Delivery: From Concept to Applications discusses the current challenges of oral drug delivery, broadly revising the different physicochemical barriers faced by nanotechnolgy-based oral drug delivery systems, and highlighting the challenges of improving intestinal permeability and drug absorption. Oral delivery is the most widely used form of drug administration due to ease of ingestion, cost effectiveness, and versatility, by allowing for the accommodation of different types of drugs, having the highest patient compliance. In this book, a comprehensive overview of the most promising and up-to-date engineered and surface functionalized drug carrier systems, as well as opportunities for the development of novel and robust delivery platforms for oral drug administration are discussed. The relevance of controlling the physicochemical properties of the developed particle formulations, from size and shape to drug release profile are broadly reviewed. Advances in both in vitro and in vivo scenarios are discussed, focusing on the possibilities to study the biological-material interface. The industrial perspective on the production of nanotechnology-based oral drug delivery systems is also covered. Nanotechnology for Oral Drug Delivery: From Concept to Applications is essential reading for researchers, professors, advanced students and industry professionals working in the development, manufacturing and/or commercialization of nanotechnology-based systems for oral drug delivery, targeted drug delivery, controlled drug release, materials science and biomaterials, in vitro and in vivo testing of potential oral drug delivery technologies.