This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.

"Annual Reports in Medicinal Chemistry "provides timely and critical reviews of important topics in medicinal chemistry together with an emphasis on emerging topics in the biological sciences, which are expected to provide the basis for entirely new future therapies.
Timely and critical reviews of important topics in medicinal chemistry

"Advances in Immunology, " a long-established and highly respected publication, presents current developments as well as comprehensive reviews in immunology. Articles address the wide range of topics that comprise immunology, including molecular and cellular activation mechanisms, phylogeny and molecular evolution, and clinical modalities. Edited and authored by the foremost scientists in the field, each volume provides up-to-date information and directions for the future.

This volume focuses on synthetic vaccines.

Key features:

* Contributions from leading authorities * Informs and updates on all the latest developments in the field

This volume of Methods in Enzymology looks at Protein Engineering for Therapeutics. The chapters providean invaluable resource for academics, researchers and students alike. With an international board of authors, this volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds
Chapters providean invaluable resource for academics, researchers and students alike. Iinternational board of authors. This volume is split into sections that cover subjects such as Antibodies, Protein conjugates, Peptides, Enzymes and Scaffolds"

This book highlights the advances in essential oil research, from the plant physiology perspective to large-scale production, including bioanalytical methods and industrial applications. The book is divided into 4 sections. The first one is focused on essential oil composition and why plants produce these compounds that have been used by humans since ancient times. Part 2 presents an update on the use of essential oils in various areas, including food and pharma industries as well as agriculture. In part 3 readers will find new trends in bioanalytical methods. Lastly, part 4 presents a number of approaches to increase essential oil production, such as in vitro and hairy root culture, metabolic engineering and biotechnology. Altogether, this volume offers a comprehensive look at what researchers have been doing over the last years to better understand these compounds and how to explore them for the benefit of the society.

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.

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

This book reviews the current strategies and challenges for the treatment of bacterial, fungal, parasitic and viral infectious diseases in developing countries. Contributing authors present expert analysis on the transmission, epidemiology, bacteriology, pathogenesis and treatment of Neglected Tropical Bacterial Diseases such as Leprosy, Buruli ulcer, and Trachoma. Particular attention is also given to current antifungal agents, their spectrum of activity, mode of action, limitations, and current challenges in antifungal therapy. The authors explore the medicinal chemistry efforts that gave rise to currently launched drugs and new anti-HIV agents, and they also highlight the latest vaccine and drug developments in the clinical management of the Ebola Virus Disease, ignited by the 2014-2016 outbreak. This work has an interdisciplinary appeal and will engage scholars and professionals in the burden of communicable diseases.

Pharmacology in Drug Discovery: Understanding Drug Response is designed for all students, recent graduates, and new researchers in the pharmaceutical and biotechnology industries who need to interpret change in physiology induced by a chemical substance. Physiological systems customize chemical signal input to their own needs; therefore the same drug can have different effects in different physiological systems. The field of pharmacology is unique in that it furnishes the tools to analyze these different behaviors and traces them to their root cause. This enables predictions of drug behavior to be made in all systems, an invaluable tool for drug discovery because almost all drugs are developed in test systems far removed from the therapeutic one.
This valuable resource provides simple explanations of the ways in which biological systems use basic biochemical mechanisms to produce fine chemical control of physiology, allowing for more informed predictions of drug effects in all systems and forming the basis of the drug-discovery process. Chapters follow a logical progression on how to characterize the pharmacology of any given molecule, and include important terminology, chapter summaries, references, and review questions to aid the reader in understanding and retention of the material.
Enables the reader to interpret drug dose-response data and make mechanistic inferences at the molecular levelBridges the gap between biochemistry and therapeutic medicineChapters include key topics such as drug affinity and efficacy, enzymes as drug targets, in vivo pharmacology, safety pharmacology, and more"

This second edition details some of the recent trends in HCS/HCA/HCI. New and updated chapters guide readers through methods that utilize reagents and kits that have been developed to measure cells and subpopulation classifications, control measures, overviews of the data handling issues associated with HCS/HCA/HCI, and methods to implement more complex phenotypic models. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, High Content Screening and Analysis-The Ideal Format for Phenotypic Screening: A Powerful Approach to Systems Cell Biology and Drug Discovery, Second Edition aims to ensure successful results in the further study of this vital field.

This edited book comprises of eight chapters dealing on various aspects of pharmaceutical technology for delivery of natural products. Book chapters deal with the solubility and bioavailability enhancement technologies for natural products. Emphasis has also been given on the significance of delivery strategies for improving the therapeutic efficacy of paclitaxel, galantamine and tea constituents.

This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.
This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.
A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry.
Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actionsManufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processesCovers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

This second edition book explores breakthrough technologies in the field of drug target identification and validation. The volume emphasizes particularly revolutionary technologies, such as CRISPR-related screening, "big data," and in silico approaches, as well as in vivo applications of CRISPR and best uses of animal models in drug development. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Fully updated and authoritative, Target Identification and Validation in Drug Discovery: Methods and Protocols, Second Edition is an ideal guide for molecular and cellular biologists, pharmacologists, pathologists, bioinformaticians, clinical researchers, or investigators, as well as experts in other fields that need a quick overview of these state-of-the-art technologies.

The book "Nanocosmetics and nanomedicines: new approaches for skin care" contains a summary of the most important nanocarriers for skin delivery. Although "nanocosmetics" is a subject widely commented in the academy and the beauty industry, a book covering the skin care treatments using nanotechnological approaches with cosmetics and nanomedicines is still missing, therefore the need for this publication. This book is divided in three parts: The first one (Part A) is devoted to a brief review on the main topics related to the skin delivery and to the introduction of the subject "nanocosmetics". The second part (Part B) presents different types of nanocarriers applied as skin delivery systems for cosmetics or drugs. The last part (Part C) shows a wide range of applications of nanotechnology on the skin care area as well as on dermatocosmetic and dermatological fields.

This book was conceived from a simple question as to why cancer is so difficult to treat. Ultimately we want to find ways to cure cancers, but that may be an elusive dream at least with the technologies we have now and expect to have in the near future. This leads the question of whether it is possible to improve current cancer treatment methods, especially from the perspective of enhancing targeted drug delivery to tumors. This volume is designed to provide information related to the difficulties in treating cancers through targeted drug delivery, our current understanding of cancer biology, and potential technologies that might be used to achieve enhanced drug delivery to tumors. An ideal drug delivery system for treating cancers would maximize the therapeutic efficacy with minimal side effects in clinical applications. The seemingly improved anticancer efficacy of the current nanoparticle-based formulations needs to be viewed from the context of very poor success rates for translation to human applications. The results of in vitro cell culture models and small animal in vivo experiments have not been extrapolated to clinical applications. Finding the reasons for the lack of successful translation is required if we are to discover approaches to substantially extend the survival time of cancer patients, and hopefully identify cures. Cancer Targeted Drug Delivery: Elusive Dream describes some answers of achieving the so far elusive dream of treating cancers like other chronic diseases with therapies that focus using improved drug delivery systems designed to better align with the unique biological and physiological properties of cancer.

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.

Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations-many of which will be nanoparticulates-can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.

Early anthropological evidence for plant use as medicine is 60,000 years old as reported from the Neanderthal grave in Iraq. The importance of plants as medicine is further supported by archeological evidence from Asia and the Middle East. Today, around 1.4 billion people in South Asia alone have no access to modern health care, and rely instead on traditional medicine to alleviate various symptoms. On a global basis, approximately 50 to 80 thousand plant species are used either natively or as pharmaceutical derivatives for life-threatening conditions that include diabetes, hypertension and cancers. As the demand for plant-based medicine rises, there is an unmet need to investigate the quality, safety and efficacy of these herbals by the "scientific methods". Current research on drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, analytical, and molecular techniques. For instance, high throughput robotic screens have been developed by industry; it is now possible to carry out 50,000 tests per day in the search for compounds which act on a key enzyme or a subset of receptors. This and other bioassays thus offer hope that one may eventually identify compounds for treating a variety of diseases or conditions. However, drug development from natural products is not without its problems. Frequent challenges encountered include the procurement of raw materials, the selection and implementation of appropriate high-throughput bioassays, and the scaling-up of preparative procedures. Research scientists should therefore arm themselves with the right tools and knowledge in order to harness the vast potentials of plant-based therapeutics. The main objective of Plant and Human Health is to serve as a comprehensive guide for this endeavor. Volume 1 highlights how humans from specific areas or cultures use indigenous plants. Despite technological developments, herbal drugs still occupy a preferential place in a majority of the population in the third world and have slowly taken roots as alternative medicine in the West. The integration of modern science with traditional uses of herbal drugs is important for our understanding of this ethnobotanical relationship. Volume 2 deals with the phytochemical and molecular characterization of herbal medicine. Specifically, It will focus on the secondary metabolic compounds which afford protection against diseases. Lastly, Volume 3 focuses on the physiological mechanisms by which the active ingredients of medicinal plants serve to improve human health. Together this three-volume collection intends to bridge the gap for herbalists, traditional and modern medical practitioners, and students and researchers in botany and horticulture.

"Annual Reports in Medicinal Chemistry "provides timely and critical reviews of important topics in medicinal chemistry together with an emphasis on emerging topics in the biological sciences, which are expected to provide the basis for entirely new future therapies.
* Covers findings related to cardiovascular, inflammation, and pulmonary diseases
* Examines issues in oncology, from mTor inhibitors to drug targets
* Incorporates up-to-date information on drug design and discovery, including delivery to market

Industrialists developing new food and pharmaceutical products face the challenge of innovation in an increasingly competitive market that must consider incredient cost, product added-value, expectations of a healthy life-style, improved sensory impact, controlled delivery of active compounds and last, but not lease, product stability. While much work has been done to explore, understand, and address these issues, a gap has emerged between recent advances in fundamental knowledge and its direct application to product situations with a growing need for scientific input.
Modern Biopolymer Science matches science to application by first acknowledging the differing viewpoints between those working with low-solids and those working with high-solids, and then sharing the expertise of those two camps under a unified framework of materials science.

* Real-world utilisation of fundamental science to achieve breakthroughs in product development
* Includes a wide range of related aspects of low and high-solids systems for foods and pharmaceuticals
* Covers more than bio-olymer science in foods by including biopolymer interactions with bioactive compounds, issues of importance in drug delivery and medicinal chemistry

Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular Biology(TM) series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.

"Annual Reports in Medicinal Chemistry" provides timely and critical reviews of important topics in medicinal chemistry together with an emphasis on emerging topics in the biological sciences, which are expected to provide the basis for entirely new future therapies.
* covers findings related to cardiovascular, inflammation, and pulmonary diseases
* examines issues in oncology, from mTor inhibitors to drug targets
* incorporates up-to-date information on drug design and discovery, including delivery to market

Statistical Methods in Food and Consumer Research continues to be the only book to focus solely on the statistical techniques used in sensory testing of foods, pharmaceuticals, cosmetics, and other consumer products.
This new edition includes the most receent applications of statistical methods, and features significant updates as well as two new chapters.
Covering the application of techniques including R-index, the Bayesian approach for sensory differences tests, and preference mapping in addition to several other methodologies, this is the comprehensive reference needed by those studying sensory evaluation and applied statistics in agriculture and biological sciences. Research professionals working with food, beverages, healthcare, cosmetics, and other related areas will find the book a valuable guide to the variety of statistical methods available.

Key Features:
* Provides comprehensive coverage of statistical techniques in sensory testing
* Includes data compiled from real-world experiments
* Covers the latest in data interpretation and analysis
* Addresses key methods such as R-index, Thursonian Discriminal Distances, group sequential tests, beta-binomial tests, sensory difference and similarity tests, just-about-right data, signal-to-noise ratio, analysis of cosmetic data, Descriptive Analysis, claims substantiation and preference mapping