This volume presents some of the latest research and applications in using natural substances and processes for pharmaceutical products. It presents an in-depth examination of the chemical and biological properties of selected natural products that are either currently used or have the potential for useful applications in the chemical and pharmaceutical industries. It covers emerging technologies and case studies and is a source of up-to-date information on the topical subject of natural products and microbial technology. It provides an applied overview of the field, from traditional medicinal targets to cutting-edge molecular techniques. Natural products have always been of key importance to drug discovery, but as modern techniques and technologies have allowed researchers to identify, isolate, extract, and synthesize their active compounds in new ways, they are once again coming to the forefront of drug discovery.

Medicinal chemistry and pharmacology are closely associated fields, and the use of natural products for their medicinal properties is ever-growing. The study of drugs from natural products and their effects on the living body are explored in this volume. The book looks into the research, discovery, and characterization of chemicals that exhibit biological effects. Providing an informative compilation of research, valuable case studies, and reviews of existing literature in the area, the book focuses on the ethnobotanical uses of natural products and phytochemicals for health care, including applications for diabetes, ulcers, wound healing, chronic alcoholism, hemorrhoidal treatment, cancer mitigation, pain management, immunotherapy, and more.

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

Handbook of Essential Oils: Science, Technology, and Applications presents the development, use and marketing of essential oils. Exciting new topics include insecticidal applications, but there is a continued focus on the chemistry, pharmacology and biological activities of essential oils. The third edition unveils new chapters including the insect repellent and insecticidal activities of essential oils, the synergistic activity with antibiotics against resistant microorganisms, essential oil applications in agriculture, plant-insect interactions, and pheromones and contaminants in essential oils. Features Presents a wide range of topics including sources, production, analysis, storage, transport, chemistry, aromatherapy, pharmacology, toxicology, metabolism, technology, biotransformation, application, utilization, and trade Includes discussions of biological activity testing, results of antimicrobial and antioxidant tests, and penetration enhancing activities useful in drug delivery Covers up-to-date regulations and legislative procedures, together with the use of essential oils in perfumes, cosmetics, feed, food, beverages, and pharmaceutical industries Unveils new chapters including the insect repellent and insecticidal activities of essential oils, the synergistic activity with antibiotics against resistant microorganisms, essential oil applications in agriculture, plant-insect interactions, and pheromones and contaminants in essential oils The American Botanical Council (ABC) named the second edition as the recipient of the 2016 ABC James A. Duke Excellence in Botanical Literature Award and recognized that essential oils are one of the fastest growing segments of the herbal product market

This book combines discursive chapters that present the latest progress in molecular biology, drug discovery, organ-tissue engineering, and related fields, with a number of descriptive chapters on methods, protocols, and case studies. Structured into four parts, this volume walks the reader through the latest in cellular biology, with discussions on novel medicinal plant metabolites, nanotechnology in precision medicine, nucleic acid-based therapeutics and vaccines, genetic engineering, computational aid, bioinformatics, synthetic organs for transplantation, and organ-tissue engineering. Written for the highly successful Methods in Molecular Biology series, chapters include the kind of detail and expert implementation advice that ensures quality results in the lab. Authoritative and informative, Gene, Drug, and Tissue Engineering serves as an ideal guide for undergraduate students, postgraduate researchers, and senior researchers working in biomedicine and its underlying technologies, stimulating both computational and experimental development and fostering the exchange of new ideas.

This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition. Key Features: Continues to be the definitive reference on drug metabolism Covers the drug transporter field, disposition of protein therapeutics and metabolic activation of drugs Includes the contributions of world-class experts in their respective fields Contains the work of editors who are recognized leaders and deep content experts in the field of drug metabolism Emphasizes new scientific and regulatory developments in the field

The purpose of this book is to focus on major considerations in the clinical use of botanicals as an integrated therapy in current health care. The book uses an organ system approach to presenting clinical evidence on the use of botanicals for common conditions. The chapters include brief sections on background and pharmacognosy, preparation and dosing, safety, evidence and clinical application. In addition, several chapters highlight pharmacokinetic and pharmacogenomic considerations with botanicals in precision medicine and their use in special populations. Finally, a summary on the editors' perspective of "challenges and opportunities" is provided, which discusses the practice of botanicals as integrative therapies and where they are heading in the future.

Medicinal Chemistry of Neglected and Tropical Diseases: Advances in the Design and Synthesis of Antimicrobial Agents consolidates and describes modern drug discovery and development approaches currently employed to identify effective chemotherapeutic agents for the treatment of Neglected Tropical Diseases (NTDs) from a medicinal chemistry perspective. Chapters are designed to cater to the needs of medicinal chemists who work with chemotherapeutic developments for NTDs, as well as serve as a guide to budding medicinal chemists who wish to work in this area. It will introduce rational drug design approaches adopted in designing chemotherapeutics and validated targets available for the purpose.

The field of molecular medicine covers the medical interventions targeting molecular structures and mechanisms that are involved in disease progression. In cancer, several molecular mechanisms have been shown to impact its progression, aggressiveness and chemoresistance. Increasing evidence demonstrates the role of nanotechnology and outcome of molecular therapy. Several books have discussed molecular biology and mechanisms involved in cancer, but this text gives an account of molecular therapeutics in cancer relating to advancements of nanotechnology. It provides a description of the multidisciplinary field of molecular medicines and its targeted delivery to cancer using nanotechnology. Key Features: Provides current information in the multidisciplinary field of molecular medicines and its targeted delivery to cancer using nanotechnology Presents important aspects of nanotechnology in the site-specific delivery of anticancer agents Includes up to date information on oligonucleotide and gene based therapies in cancer Describes small targeted molecules, antibodies and oligonucleotides which have shown to selectively target the molecular structures thereby influencing signal transduction Facilitates discussion between researchers involved in cancer therapy and nanoscientists

Regulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years. Research in Ayurveda is now a world-wide phenomenon, and several large pharmaceutical corporations are investing money for novel drug discovery from Ayurvedic sources. This book examines the regulatory and pharmacological aspects and includes extensive data on scientific evaluation carried out on Ayurvedic formulations. It will also serve as a reference book on standardization, pre-clinical studies, and clinical and toxicological studies on Ayurvedic formulations.

By covering the full spectrum of topics relevant to peptidic drugs, this timely handbook serves as an introductory reference for both drug developers and biomedical researchers interested in pharmaceutically active peptides, presenting both the advantages and challenges associated with this molecular class.
The first part discusses current approaches to developing pharmaceutically active peptides, including case studies of the use of peptidic drugs in cancer and AIDS therapy. The second part surveys strategies for the development and targeting of peptidic drugs.
With its integration of biochemical, pharmaceutical and clinical research, this work reveals the full picture of modern peptide drug research in a single volume, making it an invaluable reference for medicinal chemists, biochemists, biotechnologists, and those in the pharmaceutical and biotechnological industries.

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Ethnobotany includes the traditional use of plants in different fields like medicine and agriculture. This book incorporates important studies based on ethnobotany of different geographic zones. The book covers medicinaland aromatic plants, ethnopharmacology, bioactive molecules, plants used in cancer, hypertension, disorders of the central nervous system, and also as antipsoriatic, antibacterial, antioxidant, antiurolithiatic. The book will be useful for a diverse group of readers including plant scientists, pharmacologists, clinicians, herbalists, natural therapy experts, chemists, microbiologists, NGOs and those who are interested in traditional therapies.

Due to their high specificity and low toxicity profile, peptides have once again become central to the development of new drugs. In Peptide-Based Drug Design: Methods and Protocols, expert researchers provide a handbook which offers a selection of research and production tools suitable for transforming a promising protein fragment or stand-alone native peptide into a pharmaceutically acceptable composition. The volume delves into contemporary, cutting-edge subjects such as hit isolation and target validation, computer-aided design, sequence modifications to satisfy pharmacologists, in vivo stability and imaging, and the actual production of difficult sequences. Written in the highly successful Methods in Molecular Biology (TM) series format, chapters include readily reproducible, step-by-step laboratory protocols, lists of materials, and the Notes section, which highlights tips on troubleshooting and avoiding known pitfalls. Comprehensive and up-to-date, Peptide-Based Drug Design: Methods and Protocols shows its subject to be an independent science on the rise, and provides scientists with a clear, concise guide for continuing this vital research.

Biologically active natural products and their substructures have long been valuable starting points for medicinal chemistry and drug discovery. This new volume explores biologically active natural products and their use in microbial technologies and as phyto-pharmaceuticals in drug development. It presents detailed scientific principles and recent research on applications of nanotechnology in diagnostics and drug delivery. Topics include pharmacotherapeutically active proteins and peptides; the biotechnological potential of hydrogen-oxidizing bacteria; synthesis and production; synthetic colorants, pigments, dyes, and lakes; and more. The use of various plants is discussed in several chapters, including Artemisia, Asteraceae, Abutilon indicum, Prosopis juliflora, Acacia arabica, Aloe barbadensis, Tabermontana divaricate Linn., among others. With the information presented in Biologically Active Natural Products: Microbial Technologies and Phyto-Pharmaceuticals in Drug Development, scientists, faculty, and graduate students will gain a unique insight into nanotechnology and natural pharmaceuticals today with practical implementation in various industrial sectors.

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.

The subject of chemistry is widely acknowledged as being conceptually challenging, and regarded with a perceived elitism. This book aims to address this dilemma by breaking down the fundamentals of organic chemistry and its importance in medicine, so that readers with any or no background education in chemistry can access the material and gain an appreciation and understanding for the subject. The text is written in a clear and concise manner, using appropriate figures, to explain how the medicine we are so familiar with is designed and produced. Undergraduate students, medical and nursing students, and general audiences will benefit from the accessible format and enjoyable read. Key Features: User-friendly text dealing with the chemical sciences for the non-scientist Public understanding of science at the interface of biology and chemistry is in high demand The book serves to introduce organic chemistry and its relevance to medicine Describes the foundational principles of chemistry without losing the systematic rigor of the subject

This volume on applied pharmaceutical science and microbiology looks at the latest research on the applications of natural products for drug uses. It focuses on understanding how to apply the principles of novel green chemistry methods in the vital area of pharmaceuticals and covers the important aspects of green microbial technology in the pharmaceutical industry. Chapters include studies on the applications of natural products used in folk and regional medicines, such as for digestive problems, dermatological infections, respiratory diseases, vessel diseases, diarrhea and dysentery, ringworms, boils, fevers (antipyretic), skin and blood diseases, mouth sores, channel discharges, and even cancer. The volume also looks at medical benefit of microbial fermentation for the conservation of nutrients.

Pharmaceuticals constitute a relatively small share of the total Health Care expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford Health Care. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, and support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall Health Care system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to Health and Health Care, and its dual and often conflicting priorities of affordability and innovation, as well as the various Private and Public Policy initiatives directed at the sector. Everyone is affected by Big Pharma and the products they produce. At the Drug store, the physician's office, in front of the television, in everyday conversations, Drugs are a part of our lives. Society shapes our values toward Drugs and Drugs shape society. ("The Pill" and minor tranquilizers are good examples.) And, of course, the way Congress deliberates and Big Pharma responds has a huge impact on how Drugs affect our lives. This book is well-researched on the subject of the pharmaceutical industry, its struggles with Government, and its relationship to the consumer from the early twentieth century until the present. The Dynamic Tension between the three participants - Government, Big Pharma, and the People - is described and explained to lead to an understanding of the controversies that rage today. The author describes how the Government, its many investigatory efforts, and the ultimate legislative results affect the industry and the consequences of their activities are explored in light of their effects on other players, including the patients and consumers who rely on both Government and Big Pharma for their well-being and who find sometimes unexpected consequences while giving special attention to the attitudes, beliefs, and misadventures of less-than-optimal Drug use. Stakeholders are identified with physicians as a major focus, as well as describing the significance of prescriptions as social objects and the processes by which physicians make choices on behalf of their patients. The author ties it all together with how Big Pharma affects and is affected by each of these groups. The author utilizes his 50-plus years' experience as an academic, practicing pharmacist, and Big Pharma employee to describe the scope of the pharmaceutical industry and how it affects us on a daily basis, concluding with an inside look at Big Pharma and how regulations, marketing, and the press have affected their business, both good and bad.

Pharmaceuticals constitute a relatively small share of the total Health Care expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford Health Care. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, and support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall Health Care system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to Health and Health Care, and its dual and often conflicting priorities of affordability and innovation, as well as the various Private and Public Policy initiatives directed at the sector. Everyone is affected by Big Pharma and the products they produce. At the Drug store, the physician's office, in front of the television, in everyday conversations, Drugs are a part of our lives. Society shapes our values toward Drugs and Drugs shape society. ("The Pill" and minor tranquilizers are good examples.) And, of course, the way Congress deliberates and Big Pharma responds has a huge impact on how Drugs affect our lives. This book is well-researched on the subject of the pharmaceutical industry, its struggles with Government, and its relationship to the consumer from the early twentieth century until the present. The Dynamic Tension between the three participants - Government, Big Pharma, and the People - is described and explained to lead to an understanding of the controversies that rage today. The author describes how the Government, its many investigatory efforts, and the ultimate legislative results affect the industry and the consequences of their activities are explored in light of their effects on other players, including the patients and consumers who rely on both Government and Big Pharma for their well-being and who find sometimes unexpected consequences while giving special attention to the attitudes, beliefs, and misadventures of less-than-optimal Drug use. Stakeholders are identified with physicians as a major focus, as well as describing the significance of prescriptions as social objects and the processes by which physicians make choices on behalf of their patients. The author ties it all together with how Big Pharma affects and is affected by each of these groups. The author utilizes his 50-plus years' experience as an academic, practicing pharmacist, and Big Pharma employee to describe the scope of the pharmaceutical industry and how it affects us on a daily basis, concluding with an inside look at Big Pharma and how regulations, marketing, and the press have affected their business, both good and bad.

A new generation of technological vaccines protect against many infectious diseases. This book describes synthetic peptide-based vaccine prototypes - the future of vaccination. Production of peptides becomes simple using automatic synthesizers. Peptides are weak immunogen and need adjuvants to provide an effective autoimmune response, which is why peptide antigens are conjugated with biopolymers and loaded with nanoparticles. The book illustrates the use of peptides vaccine systems and makes predictions of future development not only for infectious diseases, but also for cancers and brain diseases such as Alzheimer, Parkinson and psychiatric diseases. Key Features Summarizes current studies on technological vaccines Describes the uses of vaccines for the prevention of brain diseases Reviews the ways different polymers are used to enhance vaccine efficacy

This book provides an extensive overview of the principles and methods of sample size calculation and recalculation in clinical trials. Appropriate calculation of the required sample size is crucial for the success of clinical trials. At the same time, a sample size that is too small or too large is problematic due to ethical, scientific, and economic reasons. Therefore, state-of-the art methods are required when planning clinical trials. Part I describes a general framework for deriving sample size calculation procedures. This enables an understanding of the common principles underlying the numerous methods presented in the following chapters. Part II addresses the fixed sample size design, where the required sample size is determined in the planning stage and is not changed afterwards. It covers sample size calculation methods for superiority, non-inferiority, and equivalence trials, as well as comparisons between two and more than two groups. A wide range of further topics is discussed, including sample size calculation for multiple comparisons, safety assessment, and multi-regional trials. There is often some uncertainty about the assumptions to be made when calculating the sample size upfront. Part III presents methods that allow to modify the initially specified sample size based on new information that becomes available during the ongoing trial. Blinded sample size recalculation procedures for internal pilot study designs are considered, as well as methods for sample size reassessment in adaptive designs that use unblinded data from interim analyses. The application is illustrated using numerous clinical trial examples, and software code implementing the methods is provided. The book offers theoretical background and practical advice for biostatisticians and clinicians from the pharmaceutical industry and academia who are involved in clinical trials. Covering basic as well as more advanced and recently developed methods, it is suitable for beginners, experienced applied statisticians, and practitioners. To gain maximum benefit, readers should be familiar with introductory statistics. The content of this book has been successfully used for courses on the topic.

Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals

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.

Medicinal plants have been used in the prevention, diagnosis, and elimination of diseases based on the practical experience of thousands of years. There is a pressing need to initiate and transform laboratory research into fruitful formulations leading to the development of newer products for the cure of diseases such as AIDS, cancer, and hepatitis, as well as coping with multi-drug resistance problems. This book presents recent developments in the research on medicinal plants for different diseases, formulation of products, and market strategy.