This book on hollow fiber contractors presents an up-to-date compilation of the latest developments and milestones in this membrane technology. Hollow Fiber Membrane Contactors: Module Fabrication, Design and Operation, and Potential Applications provides a comprehensive discussion of hollow fiber membrane applications (including a few case studies) in biotechnology, chemical, food, and nuclear engineering. The chapters in this book have been classified using the following, based on different ways of contacting fluids with each other: Gas-liquid contacting; Liquid-liquid contacting; Supported liquid membrane; Supported gas membrane; Fluid-fluid contacting. Other features include: Discusses using non-dispersive solvent extraction, hollow fiber strip dispersion, hollow fiber supported liquid membranes and role of process intensification in integrated use of these processes Provides technical and economic perspectives with several case studies related to specific scenarios Demonstrates module fabrication, design, operation and maintenance of hollow fiber contactors for different applications and performance Presents discussion on newer concepts like membrane emulsification, membrane nanoprecipitation, membrane crystallization and membrane condenser Special focus on emerging areas such as the use of hollow fiber contactor in back end of nuclear fuel cycle, membrane distillation, dehumidification of air and gas absorption and stripping Discusses theoretical analysis including computational modeling of different hollow fiber membrane processes, and presents emphasis on newly developed area of hollow fiber membrane based analytical techniques Presents discussion on upcoming area dealing with hollow fiber contactors-based technology in fermentation and enzymatic transformation and in chiral separations This book is equally suited for newcomers to the field, as well as for engineers and scientists that have basic knowledge in this field but are interested in obtaining more information about specific future applications.

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses:

• candidate drug selection
• drug discovery and development
• preformulation predictions and drug
• selections
• product design to commercial dosage form
• biopharmaceutical support in formulation
• development
• and more

Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development

In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, industry, and health organizations address various aspects of the important problems in global clinical development and MRCTs. The book first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes with an examination of the latest research topics from MRCT perspectives, such as special considerations by local health authorities, health economic evaluations, benefit-risk assessment, and medical devices. Explaining how to design, conduct, and interpret MRCTs, this book will help biostatisticians working in the late-stage clinical development of medical products. It will also be useful for statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.

Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product. Chapter 1 reviews applied enzymology while chapter 2 delineates theory and applications. Between them, the first two chapters set the appropriate backdrop for the remaining chapters, which focus on actual enzyme products that have gained regulatory approval for general medical use. The chapter authors discuss the biochemistry of the enzymes, the reactions they catalyze, how they are produced or manufactured, and their medical applications. The book highlights the many applications of approved therapeutic enzymes, including use in the treatment of blood-clotting disorders, certain cancers, and a variety of genetic disorders. Illustrated with tables and figures that support the text, the book is a single source of in-depth technical information.

With a high diversity of vegetation in Iran, over 8000 plant species are in existence. More than 2300 species of these plants have medicinal, edible and industrial properties, and more than 1700 species of them are endemic. Natural Products and Botanical Medicines of Iran provides an overview on important endemic plants and their usages. All results have been tabulated and key detailed information of each species is presented with background data. Features: Provides an understanding of indigenous plant-derived natural medicines of the most important medicinal plants in the region Includes discussions and critical views on the potentials and challenges for further development of the selected plants in a modern setting Details the important plants and sets out the chapters based on either taxonomy or medical use

This book offers a broad summary of the wild plants and their usage, as well as the growing interest in ethnopharmacology research. The book comprises of important issues such as diversity of wild plants with emphasis on medicinal and food plants, threats to wild plants and traditional ethnobotanical knowledge, their uses in skin diseases, snake-bites, in cosmeceuticals, etc. Moreover, the ethnopharmacological relevance of wild plants in Latin America has been discussed. The chapters include a wide range of case studies, giving updated evidence on the importance of their wild plant resources from different countries including Peru, Nepal, Bangladesh, India, Pakistan, Brazil. In addition, some specific species are used to explain their potential properties, as well as the dangers of their use without guidance of trained natural healers. The book discusses traditional usage and properties of wild plants and is entirely different from other related publications and useful for the researchers working in the areas of conservation biology, botany, ethnobiology, ethnopharmacology, policymakers, etc.

In order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structure and predict possible metabolic pathways in order to avoid the risk of adverse reactions that lead to the withdrawal of a drug from the market. This title is a comprehensive guide for recognizing the chemical underpinnings of drug metabolism. While there are numerous resources available to medicinal chemists for understanding drug structure, and to pharmacologists for discerning drug metabolism from a biological standpoint, no resource currently exists that links the chemical and biological aspects in language accessible to both-making it challenging for both groups to fully comprehend how a drug is metabolized, as well as the potential effects of the metabolites. Drug Metabolism: Chemical and Enzymatic Aspects provides extensive material to help understand drug metabolism within a biological context, and for predicting and mitigating adverse drug reactions.

Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials. The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving. This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.

To understand the drug interactions you must have a good grasp of the unit operations involved in making a tablet. This book's strategy is to begin with the fundamental physical and chemical processes that the different unit operations use and then apply this knowledge to the discussion of the different unit operations and processes.

Discovering & Developing Molecules with Optimal Drug-Like Properties provides a contemporary view on the latest research in the areathat will help readers benchmark current best practices, new research techniques and strategies, and understanding of informatics.Written with anunderlying theme of early collaboration opportunities between pharmaceutical and discovery sciences, emphasis is made ofpractical considerations, with the opportunities examined from a number of different perspectives to maximize utility to the reader. Questions like What properties of a molecule are important from a drug-like standpoint? and What are some of the new techniques and approaches that can be used to characterize and understand molecular properties relevant to molecule druggability? will be addressed in an objective scientific manner. The text covers: - in silico predictive tools - contemporary approaches to physiochemical measurements - case studies in lead optimization for drug-like properties - assessing the risk and challenges related to key physicochemical properties - design of molecules tailored for specific drug delivery approaches - the importance of phase discovery and selection on drug molecule development - use of physicochemical properties for preclinical formulation selection and early clinical formulations - new approaches to link physiochemical properties to formulation selection"

This book provides a broad range of applications and recent advances in the search for biofilm materials in nature. It also explains the future implications for biofilms in the areas of advanced molecular genetics, pharmaceuticals, pharmacology, and toxicology. This book is comprised of 20 chapters from leading experts in the field and it examines immunology and microbiological studies derived from biofilms as well as explores environmental, agricultural, and chemical impacts on biofilms. It is divided into five subdivisions: biofilms and its complications, biofilm infections in human body, detection of biofilm-forming pathogens, antibiofilm chemotherapy, and biofilms production tools in aquaculture. This book may be used as a text or reference for everyone interested in microbial biofilms and their current applications. It is also highly recommended for environmental microbiologists, medical microbiologists, bioremediation experts, and microbiologists working in biocorrosion, biofouling, biodegradation, water microbiology, quorum sensing, and many other related areas. Scientists in academia, research laboratories, and industry will also find it of interest. This book includes chapter homework problems and case studies. Powerpoints are also available for adopting instructors. Discusses and clarifies the resource of isolation and chemical properties from biofilms Discusses the latest pharmaceutical, pharmacological, and medicinal approaches toward the treatment of chronic and uncured diseases, such as Alzheimer's osteoporotic, sexual dysfunction, sleep sickness, allergy treatment, asthma, hair loss, AIDS, hypertension, antiaging, etc. Examines immunology and microbiological studies derived from biofilms Explores environmental, agricultural, and chemical impacts on biofilms. Dr. Bakrudeen Ali Ahmed Abdul is an Associate Professor, the Head of the Department of Biochemistry and Dean of the School of Life Sciences, Centre for Research and Development (CRD), PRIST Deemed University, Vallam, Thanjavur, Tamil Nadu, India. His research areas include the application of plant biochemistry, bioactive compound production, biotechnological methods, development of pharmaceutical products and pharmacological studies.

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

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.

In the fast-developing field of nanomedicine, a broad variety of materials have been used for the development of advanced delivery systems for drugs, genes, and diagnostic agents. With the recent breakthroughs in the field, we are witnessing a new age of disease management, which is governed by precise regulation of dosage and delivery. This book presents the advances in the use of polymeric nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. Beginning with the combinatorial approach for polymer design, it discusses star-shaped amphiphilic polymers, self-assembling polymer-drug conjugates, amphiphilic dendrimers, dendrimer nanohybrids, sustainable green polymeric nanoconstructs, chitosan-based nanogels, and multifunctional hybrid nanogels. The book provides all available information about these materials and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully.

Planar Chromatography-Mass Spectrometry focuses on a relatively new approach to chemical analysis in general, and to separation science in particular. It is the first book to systemically cover the theoretical background, techniques, instrumentation, and practical applications of planar chromatography-mass spectrometry as a hyphenated tool of analytical chemistry. It also examines the high and as-yet unexploited potential of planar chromatography-mass spectrometry for analytical use in scientific investigations. This book overviews the combination of planar chromatography, a relatively simple and cost-effective separation step for determining complex mixtures of compounds, with mass spectrometry, an efficient, highly instrumental, and relatively expensive technique that enables rapid identification of separated chemical species. It covers electrophoretic-mass spectrometry methods and applications, which are considered planar chromatographic techniques and are increasingly being exploited in proteomic and molecular biology studies as well as for medical diagnostic purposes. It also provides a selection of applications, such as drug control and forensic and food analysis, including more difficult substances such as carbohydrates and lipids. The book advocates growth in using planar chromatography-mass spectrometry in laboratories that have appropriate equipment but have not yet employed the techniques in combination. It also describes the use of a relatively inexpensive commercial system that can be adopted by laboratories currently working without the coupled methodology. Aiming to improve power and efficiency when other analytical methods are inadequate, Planar Chromatography-Mass Spectrometry encourages separation science practitioners in academia and industry to combine the two methods for enhanced results.

As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

The Silk Road, a complex network of trade routes linking China with the rest of the Eurasian continent by land and sea, fostered transformation of the ethnic, cultural, and religious identities of diverse peoples. In Natural Products of Silk Road Plants there is a treasury of plants, many indigenous to countries along the trading routes of the Silk Road, that yielded medicines, cereals, spices, beverages, dyes, and euphoric and exotic compounds previously unknown to the rest of the world. This entry in the Natural Products Chemistry of Global Plants series has been prepared for university students of chemistry and ethnobotany and for those wishing to broaden their knowledge. It opens a window on a vast region of Asia not well described for its flora and provides new and fresh insights on: Significant plants, some endangered Traditional and modern applications of extracts The biochemical and pharmacological properties of extracts Contains over 150 full colour figures The significance of the Silk Road is being revived today through immense investment by China and other eastern countries in major schemes of transport infrastructure.

One of the most promising new approaches for the prevention of HIV transmission, particularly for developing countries, involves topical, self-administered products known as microbicides. The development of microbicides is a long and complicated process, and this volume provides an overview of all the critical areas, from the selection of appropriate candidate molecules and their formulation, preclinical and clinical testing for safety and efficacy, strategies for product registration and finally, issues associated with product launch, distribution and access. The book will prove valuable to both those working in the field and all others who are interested in learning more about this product class, which has the potential to significantly impact the future of this devastating epidemic.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "

The Silk Road, a complex network of trade routes linking China with the rest of the Eurasian continent by land and sea, fostered transformation of the ethnic, cultural, and religious identities of diverse peoples. In Natural Products of Silk Road Plants there is a treasury of plants, many indigenous to countries along the trading routes of the Silk Road, that yielded medicines, cereals, spices, beverages, dyes, and euphoric and exotic compounds previously unknown to the rest of the world. This entry in the Natural Products Chemistry of Global Plants series has been prepared for university students of chemistry and ethnobotany and for those wishing to broaden their knowledge. It opens a window on a vast region of Asia not well described for its flora and provides new and fresh insights on: Significant plants, some endangered Traditional and modern applications of extracts The biochemical and pharmacological properties of extracts Contains over 150 full colour figures The significance of the Silk Road is being revived today through immense investment by China and other eastern countries in major schemes of transport infrastructure.

The book on Trends in Quorum Sensing and Quorum Quenching: New Perspectives and Applications focuses on the recent advances in the field of quorum sensing in bacteria and the novel strategies developed for quorum sensing inhibition. The topics covered are multidisciplinary and wide-ranging,and includes quorum sensing phenomenon in pathogenic bacteria, food spoilers, and agriculturally relevant bacteria. The applications of quorum sensing inhibitors such as small molecules, bioactives, natural compounds, and quorum quenching enzymes in controlling bacterial infections in clinical settings, agriculture and aquaculture are discussed. The potential use of quorum quenching enzymes for mitigating biofouling is also covered. Special focus is given to exploring quorum sensing inhibitors from microbes and flora inhabiting biodiversity rich regions including tropical rain forests and marine environments. Key features: Covers the fundamental aspects, the progress and challenges in the field of quorum sensing and quorum quenching Reviews quorum sensing in Gram-positive and Gram-negative bacteria of clinical, agricultural, and industrial relevance Discusses the application and future trends of quorum sensing inhibitors from lab to clinical and environmental settings Provides comprehensive coverage on molecular mechanisms in bacterial signaling

This book is the definitive work on the theory and practice of pharmaceutical tablet and pellet coating. It describes both the practical and theoretical aspects of tablet coating, including the equipment and methods used in laboratory development, scale-up and production systems, More...as well as automation and validation. This book also discusses the problems of conforming to world-wide regulations, and the hazards of environmental pollution.