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.

Describes the ways Vitamin C can inhibit, perturb or retard the growth and spread of cancer through changing the ways cancers respond to different doses and treatmentsSumarizes the results of clinical trialsOutlines therapeutical usesChapters by an international team of researchers.

Covers four pillars of safety statistics: cross-disciplinary scientific engagement, effective and efficient operational process, visual analytics, and intelligent data architecture Links safety monitoring to benefit risk evaluation Presents an emerging topic that links to ICH E19 and TransCelerate safety efforts

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.

We have surpassed the omics era and are truly in the Age of Molecular Therapeutics. The fast-paced development of SARS-CoV-2 vaccines, such as the mRNA vaccines encoding the viral spike protein, demonstrated the need for and capability of molecular therapy and nanotechnology-based solutions for drug delivery. In record speed, the SARS-CoV-2 viral RNA genome was sequenced and shared with the scientific community, allowing the rapid design of molecular therapeutics. The mRNA vaccines exploit the host cell endoplasmic reticulum to produce viral spike proteins for antigen presentation and recognition by the innate and adaptive immune system. Lipid nanoparticles enable the delivery of the fragile, degradation-sensitive nucleic acid payloads. Molecular-based therapeutics and nanotechnology solutions continue to drive the scientific and medical response to the COVID-19 pandemic as new mRNA, DNA, and protein-based vaccines are developed and approved and the emergency use approved vaccines are rapidly manufactured and distributed throughout the globe. The need for molecular therapies and drug delivery solutions is clear, and as these therapies progress and become more specialized there will be important advancements in organelle targeting. For example, using organelle targeting to direct lipid nanoparticles with mRNA payloads to the endoplasmic reticulum would increase the efficacy of mRNA vaccines, reducing the required dose and therefore the biomanufacturing demand. Likewise, improving the delivery of DNA therapeutics to the nucleus would improve efficacy. Organelles and molecules have always been drug targets, but until recently we have not had the tools or capability to design and develop such highly specific therapeutics. Organelle targeting has far-reaching implications. For example, mitochondria are central to both energy production and intrinsic apoptosis. Effectively targeting and manipulating mitochondria has therapeutic applications for diseases such as myopathies, cancer, neurodegeneration, progerias, diabetes, and the natural aging process. The SARS-CoV-2 vaccines that exploit the endoplasmic reticulum (for mRNA vaccines) and the nucleic translational process (DNA vaccines) attest to the need for organelle and molecular therapeutics. This book covers the status, demand, and future of organelle- and molecularly targeted therapeutics that are critical to the advancement of modern medicine. Organelle and molecular targeting is the drug design and drug delivery approach of today and the future; understanding this approach is essential for students, scientists, and clinicians contributing to modern medicine.

This book addresses the highly relevant and complex subject of research on drugs from natural products, discussing the current hot topics in the field. It also provides a detailed overview of the strategies used to research and develop these drugs. Respected experts explore issues involved in the production chain and when looking for new medicinal agents, including aspects such as therapeutic potential, functional foods, ethnopharmacology, metabolomics, virtual screening and regulatory scenarios. Further, the book describes strategic methods of isolation and characterization of active principles, biological assays, biotechnology of plants, synthesis, clinical trials and the use of tools to identity active principles.

This timely volume explores the impact of autophagy in various human diseases, emphasizing the cell biological aspects and focusing on therapeutic approaches to these diseases. The chapters cover autophagy and its potential applications on diseases ranging from obesity, osteoarthritis, pulmonary fibrosis, and inflammation, through ALS, Parkinson's, retinal degeneration, breast cancer, alcoholic liver disease and more. The final chapters round out the book with a discussion of autophagy in drug discovery and 'bench to bedside'. Chapters are contributed by leading authorities and describe the general concepts of autophagy in health and disease, marrying cell biology and pharmacology and covering: studies derived from preclinical experiments, manufacturing considerations,and regulatory requirements pertaining to drug discovery and manufacturing and production. This volume will be useful for basic scientists as well as already practicing clinicians and advanced graduate students.

Most adults take at least one prescription medication for example, for high blood pressure, high cholesterol levels, depression, asthma, diabetes, COPD, or a variety of other reasons, but most people (and many healthcare providers) are totally unaware that medications can have direct negative effects on sexual functioning and performance. This informative and timely book written by three well-known medications experts explores the chemistry behind sexual arousal in men and women and clearly and authoritatively explains how the common categories of prescription and over-the-counter medications and abused substances might be the reason for their declining sexual performance or even interest.

The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

Summarizes signaling pathways regulated by redox reactions Reveals how redox pathways affect cancer and tumor cell metastasis Chapters by an internationals team of leading researchers Chapters describe redox regulation influences developmental processes and these processes originated even before there was much oxygen in the atmosphere

This book presents an overview of the current status of translating the RNAi cancer therapeutics in the clinic, a brief description of the biological barriers in drug delivery, and the roles of imaging in aspects of administration route, systemic circulation, and cellular barriers for the clinical translation of RNAi cancer therapeutics, and with partial content for discussing the safety concerns. It then focuses on imaging-guided delivery of RNAi therapeutics in preclinical development, including the basic principles of different imaging modalities, and their advantages and limitations for biological imaging. With growing number of RNAi therapeutics entering the clinic, various imaging methods will play an important role in facilitating the translation of RNAi cancer therapeutics from bench to bedside. RNAi technique has become a powerful tool for basic research to selectively knock down gene expression in vitro and in vivo. Our scientific and industrial communities have started to develop RNAi therapeutics as the next class of drugs for treating a variety of genetic disorders, such as cancer and other diseases that are particularly hard to address with current treatment strategies. Key Features Provides insight into the current advances and hurdles of RNAi therapeutics. Accelerates RNAi, miRNAs, and siRNA drug development for cancer therapy from bench to bedside. Addresses various modifications and novel delivery strategies for miRNAs, piRNAs and siRNA delivery in anticancer therapeutics. Explores the need for the interaction of hematologists,cell biologists, immunologists, and material scientists in the development of novel cancer therapies. Describes the current status of clinical trials related to miRNA and siRNA-based cancer therapy Presents remaining issues that need to be overcome to establish successful therapies.

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

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

Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval. Key Features: Reviews withdrawn draft guidance on analytical similarity assessment. Evaluates various methods for analytical similarity evaluation based on FDA's current guidelines. Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability. Discusses the feasibility and validity of the non-medical switch studies. Provides innovative thinking for detection of possible reference product change over time. This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions.

Withania is a genus of the nightshade family of flowering plants distributed in the subtropical regions from the Mediterranean to South East Asia. Only two species, W. somnifera and W. coagulans, are found in India. The most common species is W. somnifera (WS), which occurs naturally in the subtropical regions from the Mediterranean through Africa to the Middle East, the Indian Continent, Sri Lanka, South East Asia, subtropical America and Australia. It is a perennial shrub that grows to 75 cm (.75 m) tall with tomentose branches, oval yellowish green leaves, orange red berries and a papery calyx, and it survives harsher climatic conditions. In Ayurveda it is believed the plants which survive harsh conditions have strong healing and tonification properties. The main bioactive phytoconstituents of WS are withanolides (steroidal lactones), alkaloids, flavonoids, sterols, phenolics and others. Among the various withanolides, withanolide A, withaferin A, withanone and withanolide D are the most abundant, having various activities. WS is a wonder herb with a broad spectrum of pharmacological properties, such as antioxidant, antidepressant, aphrodisiac, antiulcerogenic, antivenom, anti-inflammatory, antiarthritic, anticancer, antiparasitic, antimicrobial, anticancerous, antidiabetic, antitumor, hemopoetic neuroregenerative, immunomodulatory, cardioprotective, radio-sensitizing, rejuvenating, antistress, sedative, hypoglycemic, thyroprotective, adaptogenic, antispasmodic, immunomodulatory, immunostimulant and antiaging properties. The simultaneous quantitative analysis of six major bioactive withanolides in five varieties of WS and in different plant parts (root, stem and leaf) of WS was accomplished. This method is also applicable to control the quality of commercially formulated products which contain WS bioactive compounds. Results indicated the WS variety NMITLI-135 showed the maximum abundance of withanolides at pH 8.5, EC-0.5 dS m 1, ESP-13 in sodic soil. Our results showed this readily available, rapid and reliable method is suitable for the routine analysis and effective quality control of raw materials and finished products. FEATURES Presents a collection of Ayurvedic features and scientific analytical and pharmacological evidence of important medicinal plants of Withania somnifera Useful for natural product researchers, faculty, students and herbal product manufacturers Uses advanced hyphenated techniques for assessing phytoconstituents

An introductory but detailed treatise which includes some 1,000 references and solved examples and end-of-chapter problems, making it useful to both students and practitioners. The pharmokinetics, pharmacodynamics, and biological and biopharmaceutical parameters pertinent to each route of administra

Medicinal Chemistry: A Look at How Drugs Are Discovered is written for those who are interested in learning how drugs are discovered. Compared to other books on the market, this text takes a different approach by presenting the subject on chemical reaction mechanism terms, which ideally makes the subject matter more interesting and easier to comprehend. The authors describe the drug discovery process, from advancing an initial lead to the approval process, and include drug discovery sources. Additional features: Explains medicinal chemistry on chemical mechanism terms, allowing for a more interesting and easier to comprehend text Includes valuable insights toward the various pathways taken at pharmaceutical industries in drug discoveries Improved by including questions raised and suggestions made from students in the authors' medicinal chemistry classes This book will benefit both upper level undergraduates and graduates studying in the fields of medicinal chemistry and drug discovery, as well as scientists working in the pharmaceutical industry.

Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers ? A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges ? A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1) ? Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs: ? A perspective on the role of the intention-to-treat principle ? Examples and case studies from various areas ? Example code in SAS and R ? A connection with causal inference ? Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

The rich biodiversity of Borneo provides many useful plants for medicinal purposes. Written by experts in the field, Medicinal Plants of Borneo provides a guide and introduction to the medicinal plants from Borneo used traditionally as well as plants whose medicinal uses have been recently discovered. These include anti-HIV plants - such as Calophyllum lanigerum (calanolide A) - and anti-cancer plants - such as Aglaia foveolata (silvestrol). The book also provides information on the relevant medicinal chemistry, such as isolated bioactive compounds and the mechanism of action, where available. FEATURES Discusses the rich experience in the use of medicinal plants and the wide diversity of Borneo's botanical resources Presents plants with medicinal properties from a scientific perspective Provides readers with current information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers a range of chemical, botanical and pharmacological diversities Forms an important part of the Natural Products Chemistry of Global Plants series due to an increasing global interest in natural products and botanical drugs Simon Gibbons is Head of the School of Pharmacy, University of East Anglia, UK, and a Professor of Natural Product Chemistry. He was formerly a Professor of Medicinal Phytochemistry at the School of Pharmacy, University College London (UCL). Stephen P. Teo is a forest botanist with the Forest Department, Sarawak, Malaysia.

The new volume takes an interdisciplinary look at current technical challenges and recent developmental trends in microbial biotechnology. It covers an avalanche of new information available through research by focusing on a broad spectrum of issues on different microorganisms and their recent applications and implications in agriculture, soil science and forestry, industry, and public health and medicine. Microbes present in our immediate environment have a direct or indirect influence leading to either a harmful or beneficial effect. Microbial Biotechnology: Technological Challenges and Developmental Trends is divided into four major sections that focus on Part I: Antimicrobial Agents: Role and Applications in Medicine and Health Care Part II: Role of Microorganisms in Agriculture and Plant Biotechnology Part III: Microbial Enzymes and Their Potential Industrial Applications Part IV: Microorganisms in Environment: Role and Industrial Applications Topic include organic chemistry, biomass conversion, optimal production processes for different microbes, screening methods, and application of omics approaches such as (meta) genomics, proteomics, and metabolomics, or other biotechnology tools, to provide a deeper understanding of the microbial-based new and emerging products, trends, processes, and technologies. The chapters present unbiased original research results on microbes by incorporating case studies wherever appropriate. Providing research findings applicable to the development of new methodologies, applications, and technologies, the book will be a valuable resource for people working in various fields of microbiology.

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.

* provides an in-depth discussion of recent advances in sterilization * identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions * explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results * New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.

There is an increasing interest in plants of the Moringa genus used as a source of phytochemicals with biopharmaceutical potential, as a functional ingredient in many products and as an additive in poultry feeding stocks. Biological and Pharmacological Properties of the Genus Moringa is the first publication to comprehensively assess the latest research on Moringa studies. This book reviews recent studies covering the botanical, agronomical, genomic, biotechnological, and ethnopharmacological aspects. It presents specialized work in a user-friendly way that will appeal to undergraduates, graduates and researchers primarily in ethnopharmacology, functional foods and with a linkage to veterinary treatments. Key Features: Describes the ethnopharmacological and ethnobotanical use of plants from all Moringa species Presents recent information that will be helpful for the future development of biopharmaceuticals Reviews the phytochemical content from all Moringa species Assesses the potential of all Moringa species as a functional ingredient