Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.

This book covers recent advances of the fragment molecular orbital (FMO) method, consisting of 5 parts and a total of 30 chapters written by FMO experts. The FMO method is a promising way to calculate large-scale molecular systems such as proteins in a quantum mechanical framework. The highly efficient parallelism deserves being considered the principal advantage of FMO calculations. Additionally, the FMO method can be employed as an analysis tool by using the inter-fragment (pairwise) interaction energies, among others, and this feature has been utilized well in biophysical and pharmaceutical chemistry. In recent years, the methodological developments of FMO have been remarkable, and both reliability and applicability have been enhanced, in particular, for non-bio problems. The current trend of the parallel computing facility is of the many-core type, and adaptation to modern computer environments has been explored as well. In this book, a historical review of FMO and comparison to other methods are provided in Part I (two chapters) and major FMO programs (GAMESS-US, ABINIT-MP, PAICS and OpenFMO) are described in Part II (four chapters). dedicated to pharmaceutical activities (twelve chapters). A variety of new applications with methodological breakthroughs are introduced in Part IV (six chapters). Finally, computer and information science-oriented topics including massively parallel computation and machine learning are addressed in Part V (six chapters). Many color figures and illustrations are included. Readers can refer to this book in its entirety as a practical textbook of the FMO method or read only the chapters of greatest interest to them.

Recent research in science establishes a direct relation between human gut and skin. Several species of live microbes inhabit the human skin and intestines which far outnumbers the mammalian cells in the human body. Research interest of Nextgen scientists is focused on beneficially harnessing this microbial population to address skin disorders like acne, rosacea, eczema, premature aging, and skin cancer which are established to be a result of skin-microbiome dysbiosis. This volume highlights evidence-based endeavours of the scientific community in this sector. Currently there is no concrete literature which gives a detailed vision on the relationship between gut microbiota and skin related disorders. This volume is an attempt to put together available data in the area and demonstrate usefulness of probiotics as a new therapeutic option for management of these skin diseases which currently show poor prognosis, high cost of treatment and compromised quality of life of the patient.

"Pharmaceutics: Basic Principles and Application to Pharmacy Practice" is a valuable textbook covering the basic science as well as the role and application of pharmaceutics within pharmacy practice. Based on curricular guidelines mandated by the American Council for Pharmacy Education (ACPE), this book incorporates laboratory skills by identifying portions of each principle that can be used in a clinical setting. In this way, instructorsare able to demonstrate their adherence to ACPE standards and objectives simply by using this book. A companion website for students and instructors further enhance the didactic content for students by including practice questions and answers and videos that feature difficult processes and procedures. Essential resources for instructors are also available and include chapter PowerPoint slides and full-color images. Full of practical examples and case studies for experiential learning, "Pharmaceutics" enables students to gain the scientific foundation to understand drug physicochemical properties, practical aspects of dosage forms and drug delivery systems, and the biological applications of drug administration.
Chapter objectives and chapter summaries illustrate and reinforce key ideasDesigned to meet curricular guidelines for pharmaceutics and laboratory skills mandated by the Accreditation Council for Pharmacy Education (ACPE) Companion website features resources for students and instructors, including videos illustrating difficult processes and procedures and practice questions and answers. Instructor resources include Powerpoint slides and a full-color image bank"

Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.

This monograph compiles updated information about forskolin, a labdane diterpene that is produced by the Coleus plant. Forskolin has a large number of practical uses and the book delves into the various aspects of this chemical. It includes topics such as the botanical source of forskolin and the cultivation of Coleus forskohlii, source. It also covers the biosynthetic pathways in natural sources and also through different biotechnological applications. Chapters include the potential and products in the Forskolin market. The book also covers the methods for enhanced production of forskolin from natural sources and through tissue culture methods for improvement of the plant for higher content of forskolin. It discusses the role of endophytes in the production of forskolin. The book is useful for students and researchers in the field of botany, pharmacology and biochemistry. It also serves scientists in various pharmaceutical industries.

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

Increase in antibiotic resistance has forced researchers to develop new drugs against microorganisms. Lipopeptides are produced as secondary metabolites by some microorganisms. Computer-aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates provides the identification of novel ligands for different antimicrobial lipopeptides. Along with identification, it also provides some of the in silico drug design processes, namely homology modelling, molecular docking, QSAR studies, drug ADMET studies and pharmacophore studies to check the ligand-lipopeptide interaction. Some lipopeptides have shown anti-cancerous properties too, and this book discusses the required templates to design new drugs using computational techniques. Key Features: Focuses on the use lipopeptides as new antimicrobial compounds Presents the basics of in silico modelling for design and development of new drug molecules, and is therefore of interest to beginners in the field Provides a step-by-step process for identification of drug molecules and testing its efficacy in silico Couples with courses on patents and intellectual property rights

Includes cutting edge information regarding the very lastest environmental threats to public health Provides a detailed case study based on real-world scenario that allows the reader to practice human health risk assessment Describes innovative guidance and tools to respond to chemical incidents and attacks, which facilitates the reader to tailoring a effective protection and remediation response

A contribution to the series on Natural Products Chemistry of Global Plants, Natural Products Chemistry of Botanical Medicines from Cameroon focuses on the sources and chemistry of natural products from plants in Cameroon, West Africa. The plants selected offer an opportunity to trace a route through history from ancient civilizations to the modern day, showing the important value to man of natural products in medicines and in foods. This book highlights how many of the extracts from Cameroon are today associated with important drugs, nutrition products, beverages, perfumes, cosmetics and pigments, as well as presenting their complex chemistry and structure. Key Features: Forms an important part of the series on Natural Products Chemistry of Global Plants, as Cameroon is a country with rich experience in the use of medicinal plants and with a wide diversity of botanical resources Addresses the current development of pharmacognosy research in Cameroon Provides readers with updated information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers an extensive range of chemical, botanical and pharmacological diversities Xavier Siwe Noundou is a Scholar/Scientist based at Rhodes University in Grahamstown, South Africa. He has been a EU FP7 Marie Curie Fellow (2015-2016), Kaposvar University in Hungary (2015, 2016), Trakia Univesity in Bulgaria (2016), TWAS Fellow (2013), National Research Foundation South Africa Fellow (2014-2016). Dr Noundou works on Medicinal Chemistry focusing on Chemistry, Pharmacognosy and Nanotechnology. His main research interests include terrestrial natural products chemistry (from Cameroon and South Africa) and marine natural products chemistry (from the South African coastline): bioactive metabolites isolated as potential antiparasitic, antimicrobial, antiviral and antiproliferative candidates. He is author of more than forty scientific publications in his field of expertise.

A contribution to the series on Natural Products Chemistry of Global Plants, Natural Products Chemistry of Botanical Medicines from Cameroon focuses on the sources and chemistry of natural products from plants in Cameroon, West Africa. The plants selected offer an opportunity to trace a route through history from ancient civilizations to the modern day, showing the important value to man of natural products in medicines and in foods. This book highlights how many of the extracts from Cameroon are today associated with important drugs, nutrition products, beverages, perfumes, cosmetics and pigments, as well as presenting their complex chemistry and structure. Key Features: Forms an important part of the series on Natural Products Chemistry of Global Plants, as Cameroon is a country with rich experience in the use of medicinal plants and with a wide diversity of botanical resources Addresses the current development of pharmacognosy research in Cameroon Provides readers with updated information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers an extensive range of chemical, botanical and pharmacological diversities Xavier Siwe Noundou is a Scholar/Scientist based at Rhodes University in Grahamstown, South Africa. He has been a EU FP7 Marie Curie Fellow (2015-2016), Kaposvar University in Hungary (2015, 2016), Trakia Univesity in Bulgaria (2016), TWAS Fellow (2013), National Research Foundation South Africa Fellow (2014-2016). Dr Noundou works on Medicinal Chemistry focusing on Chemistry, Pharmacognosy and Nanotechnology. His main research interests include terrestrial natural products chemistry (from Cameroon and South Africa) and marine natural products chemistry (from the South African coastline): bioactive metabolites isolated as potential antiparasitic, antimicrobial, antiviral and antiproliferative candidates. He is author of more than forty scientific publications in his field of expertise.

Vitamin C holds a unique place in scientific and cultural history. In this book, a group of leading scientific researchers describe new insights into the myriad ways vitamin C is employed during normal physiological functioning. In addition, the text provides an extensive overview of the following: the rationale for utilizing vitamin C in the clinic, updates on recent uses of vitamin C in cancer treatment through high-dose intravenous therapies, the role vitamin C plays in the treatment of sepsis and infectious disease, management of the ways vitamin C can improve stem cell differentiation, as well as vitamin C use in other important health situations. Features Includes chapters from a team of leading international scholars Reviews the history and recent research on the functions, benefits, and uses of vitamin C Focuses special attention on the way vitamin C can be used in the treatment of cancers Discusses how vitamin C can be employed against infectious disease

This groundbreaking work calls for the overhaul of traditional Ayurveda and its transformation into a progressive, evidence-based practice. This book begins by looking back at the research of the last three centuries, Indian medicinal plants, and Ayurveda in a twenty-first-century context. The first part of this book explores the limitations of contemporary Ayurvedic pharmacognosy and pharmacology, discussing the challenges the practice faces from research and clinical trials. It makes a compelling argument for the necessity of change. The second part of the book defines and elaborates upon a new, scientific path, taking the reader from identification of the herb through all stages of drug development. An essential tool for herbal drug development, this text is designed for knowledgeable students, practitioners, and scholars of Ayurveda, pharmacy, and herbal medicine.

Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights. The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act. By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors.

Discusses endogenous benzodiazepine-like substances - what do they do, do they affect the anti-anxiety drugs and their adverse effects? Presents information on the enigmatic prolonged benzodiazepine withdrawal syndrome Describes the compounds acting at the BDZ binding sites, both exogenous (classical BDZ drugs and BDZ from food and plants) and endogenous (endozepines) Assesses the putative interactions in physiology, pathology and pharmacology of the compounds acting at the BDZ binding sites

Discusses endogenous benzodiazepine-like substances - what do they do, do they affect the anti-anxiety drugs and their adverse effects? Presents information on the enigmatic prolonged benzodiazepine withdrawal syndrome Describes the compounds acting at the BDZ binding sites, both exogenous (classical BDZ drugs and BDZ from food and plants) and endogenous (endozepines) Assesses the putative interactions in physiology, pathology and pharmacology of the compounds acting at the BDZ binding sites

This new volume focuses on clinical biochemistry fundamentals, cell culture techniques, and drug discovery and development concepts. It deals with three different fields of clinical research: cell culture, clinical biochemistry, and drug discovery and development. The book introduces cell animal and bacterial culture techniques and their potential uses as well as cell culture techniques. The biochemistry aspect of the book covers the principles of clinical biochemistry and biochemical analysis, biochemical aids to clinical diagnosis, measurement, and quality control. The book also presents important concepts in cell membrane receptor signal transduction pathways as drug targets. The drug development focus of the book discusses the fundamentals of human disease and drug discovery. Various in silico, in vitro, and in vivo approaches for drug discovery are examined, along with a discussion on drug delivery carriers and clinical trials. Overall, the volume provides an overview of the journey from clinical fundamentals to clinical output.

Covering the skills needed for pharmaceutical care in a patient-centered pharmacy setting, Clinical Skills for Pharmacists: A Patient-Focused Approach, 3rd Edition describes fundamental skills such as communication, physical assessment, and laboratory and diagnostic information, as well as patient case presentation, therapeutic planning, and monitoring of drug intake. Numerous case examples show how skills are applied in clinical situations. Now in full color, this edition adds more illustrations and new coverage on taking a medication history, physical assessment, biomarkers, and drug information. Expert author Karen J. Tietze provides unique, pharmacy-specific coverage that helps you prepare for the NAPLEX and feel confident during patient encounters. Coverage of clinical skills prepares you to be more involved with patients and for greater physical assessment and counselling responsibilities, with discussions of communication, taking a medical history, physical assessment, reviewing lab and diagnostic tests, and monitoring drug therapies. A logical organization promotes skill building, with the development of each new skill building upon prior skills. Learning objectives at the beginning of each chapter highlight important topics. Self-assessment questions at the end of each chapter help in measuring your comprehension of learning objectives. Professional codes of ethics are described in the Ethics in Pharmacy and Health Care chapter, including confidentiality, HIPAA, research ethics, ethics and the promotion of drugs, and the use of advance directives in end-of-life decisions. Numerous tables summarize key and routinely needed information. Downloadable, customizable forms on the companion Evolve website make it easier to perform tasks such as monitoring drug intake and for power of attorney. A full-color design and an increase to 150 photos and drawings better illustrates concepts, techniques, and equipment. Updated Taking Medication Histories chapter includes added coverage of the data to obtain while taking a medication history, as well as additional sections on obtaining medication names, on-demand medication information, and the pharmacist's role in immunization. Updated and expanded Physical Assessment Skills chapter includes detailed descriptions of commonly used equipment and vital signs, with more pharmacist-specific examples, so you can feel more confident in handling real-life situations. Updated Researching and Providing Drug Information chapter reflects current technology and information sources, and includes review questions on drug information. A new biomarker section in the Review of Laboratory and Diagnostic Tests chapter aids in treatment planning, explaining the different types of biomarkers and how they are used. Skills checklists cover how to perform clinical skills, such as developing a monitoring plan. Application activities at the end of each chapter include more case studies to help you apply concepts and solve problems. A Chapter Acronym Index conveniently located on the front and back inside covers offers easy lookup for many commonly used acronyms and their definitions. Video clips on the companion Evolve website show a pharmacist performing various clinical skills, including history taking and physical assessment. Animations on Evolve show key disease states and highlight other relevant concepts, and an audio glossary includes pronunciations of 241 terms.

Generally speaking, quantitative-structure activity relationship (QSAR) is a technique which correlates the biological activities of a set of compounds to their structures using a mathematical equation represented in its general form by Biological Activity = f (x1, ..., xn), where f is a mathematical function and x1, ..., xn are n molecular descriptors. Since the introduction of the initial concept of QSAR in the early 1960s, numerous advances have been introduced into the field transforming it into an essential tool in drug discovery and medicinal chemistry. Quantitative Structure - Activity Relationship: A Practical Approach provides a detailed overview of computational approaches in QSAR studies. It covers the applications of different algorithms in various steps of a QSAR analysis and shows clear examples. Each chapter introduces the tools and software involved. Moreover, challenges and issues which may be faced in any step of the analysis are thoroughly broken down based on the OECD guidelines, enabling the reader to familiarize themselves with potential end results. The book was kept concise, making it suitable for students (pharmacy, chemistry and biological science) and lecturers, as well as researchers in the field.

Provides the first accessible introduction to concepts and strategies employed in clinical trials of drugs. Also covers essential strategies and proctical insights on clinical research methodology.

Pharmaceutical Calculations: A Conceptual Approach, is a book that combines conceptual and procedural understanding for students and will guide you to master prerequisite skills to carry out accurate compounding and dosage regimen calculations. It is a book that makes the connection between basic sciences and pharmacy. It describes the most important concepts in pharmaceutical sciences thoroughly, accurately and consistently through various commentaries and activities to make you a scientific thinker, and to help you succeed in college and licensure exams. Calculation of the error associated with a dose measurement can only be carried out after understanding the concept of accuracy versus precision in a measurement. Similarly, full appreciation of drug absorption and distribution to tissues can only come about after understanding the process of transmembrane passive diffusion. Early understanding of these concepts will allow reinforcement and deeper comprehension of other related concepts taught in other courses. More weight is placed on the qualitative understanding of fundamental concepts, like tonicity vs osmotic pressure, diffusion vs osmosis, crystalloids vs colloids, osmotic diuretics vs plasma expanders, rate of change vs rate constants, drug accumulation vs drug fluctuation, loading dose vs maintenance dose, body surface area (BSA) vs body weight (BW) as methods to adjust dosages, and much more, before considering other quantitative problems. In one more significant innovation, the origin and physical significance of all final forms of critical equations is always described in detail, thus, allowing recognition of the real application and limitations of an equation. Specific strategies are explained step-by-step in more than 100 practice examples taken from the fields of compounding pharmacy, pharmaceutics, pharmacokinetics, pharmacology and medicine.

This volume of Pharmaceutical Biocatalysis starts with a discussion on the importance of biocatalytic synthesis approaches for a sustainable and environmentally friendly production of pharmaceuticals and active pharmaceutical ingredients. Among the enzymes discussed in detail with respect to their pharmaceutical relevance are cyclic nucleotide phosphodiesterases playing an important role in modulating signal transduction in various cell types; human DOPA decarboxylase, related to Parkinson's disease and aromatic amino acid decarboxylase deficiency; and phospholipase D enzymes as drug targets. Isocitrate dehydrogenase 1 and 2 mutations are novel therapeutic targets in acute myeloid leukemia. An additional chapter is devoted to the use of enzymes for prodrug activation in cancer therapy. The other topics include small-molecule inhibitors targeting receptor tyrosine kinases in cancer, -Lactams and related compounds as antibacterials, non-vitamin K oral anticoagulants for the treatment of thromboembolic diseases, and the molecular mechanisms for statin pleiotropy and its clinical relevance in cardiovascular diseases. The last chapter is a review of lysosomal storage disorders with an overview of approved drugs for treating these disorders by enzyme replacement therapy.