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

Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.

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.

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: * Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies * Authors from different major pharmaceutical and biotechnology companies * Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

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

The pharmaceutical industry recognizes the shift to the use of natural products while also considering the serious concerns that have arisen regarding the claimed efficacy, quality, and safety of these products. This volume showcases how pharmaceutical and nutraceutical compounds from natural products can be used to cure or prevent diseases. The chapters explore the connections between agrochemicals and pharmaceuticals and the use of plants and plant products in the formulation and development of new pharmaceuticals and nutraceuticals.

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

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.

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.

This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

This timely book provides a succinct summary of methods for the synthesis of bioactive heterocycles using a multicomponent reaction (MCR) approach. The majority of pharmaceuticals and biologically active agrochemicals are heterocycles while countless additives and modifiers used in industrial applications are heterocyclic in nature. With the recent introduction of high-throughput biological evaluation, the importance of MCRs for drug discovery has been recognized and considerable efforts have been focused especially on the design and development of multi-component procedures for the generation of various bioactive heterocycles due to their significant therapeutic potential.

This book covers the recent innovations relating to various bioactive natural products (such as alkaloids, glycosides, flavonoids, anthraquinones, steroids, polysaccharides, tannins and polyphenolic compounds, volatile oils, fixed oils, fats and waxes, proteins and peptides, vitamins, marine products, camptothecin, piperines, carvacrol, gedunin, GABA, ginsenosides) and their applications in the pharmaceutical fields related to academic, research and industry.

Rauvolfia species, commonly known as Sarpagandha, has been traditionally used in Ayurveda for curing high blood pressure, hypertension, snake bites, fever, and mental illnesses. Due to its wide variety and differences in chemical composition, it is necessary to develop an efficient and reliable method for rapid screening and determination of phytochemicals in the extracts of the Rauvolfia species. This book will provide qualitative and quantitative comparative phytochemical investigations of selected medicinal plants from the Rauvolfia genus using liquid chromatography-mass spectrometry (LC-MS) techniques. The results will help in assuring the efficacy and safety of Rauvolfia herbal products. Features: Collection of Ayurvedic features and scientific evidence of important medicinal plants. Discusses chemical signatures for the identification of Rauvolfia (Sarpagandha) and its products. Easy-to-use analytical procedure for quality control of Rauvolfia and its products.

Tinospora cordifolia stem is used as a tonic, vitalizer, and as a remedy for metabolic disorders to treat allergies, diabetes, dysentery, jaundice, heart diseases, leprosy, rheumatoid arthritis, skin diseases, and urinary disorders. It shows anti-inflammatory, analgesic, antipyretic actions and immunosuppressive effects. This book focuses on providing gender and geographical location-based differences in the phytoconstituents of T. cordifolia by the liquid chromatography mass spectrometric method. These methods have potential use in the quality control of T. cordifolia and the screening of herbal preparations. Features: Compilation of ayurvedic features of one of the most important plants of the Indian system of medicines. Useful for all ayurvedic practitioners, researchers, faculty, students, and herbal product manufacturers. Application of advance hyphenated LC-MS techniques for variation study in phytoconstituents.

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

This book is the first to provide both a broad overview of the current methodologies being applied to drug design and in-depth analyses of progress in specific fields. It details state-of-the-art approaches to pharmaceutical development currently used by some of the world's foremost laboratories. The book features contributors from a variety of fields, new techniques, previously unpublished data, and extensive reference lists.

Algal and sustainable technologies: Bioenergy, Nannotechnology and Green chemistry is an interdisciplinary overview of the world’s major problems; water scarcity, clean environment and energy and their sustenance remedy measures using microalgae. It comprehensively presents the way to tackle the socio-economic issues including food, feed, fuel, medicine and health and also entails the untapped potential of microalgae in environmental management, bioenergy solution and sustainable synthesis of pharmaceutical and nutraceutical products. This book basically emphasizes the success of algae as wonderful feed stocks of future and provides upto date information and sustainable and recreational outlook towards degrading environment and energy crisis. Applicability of fast emerging algae based nanotechnology in bioremediation and production of nanoparticle (AuNP, AgNP etc) are beautifully described along with latest research and findings. Key features: The "waste to best to income" strategies are the main concern of the book and take the edge off the problem of pollution, energy and income. Elucidate the sustainable phycoremediation and nanoparticle functions as low cost approach for various ecosystem services. Information regarding pharmaceuticals, nutraceuticals and other algae based value added product synthesis and fate are comprehensively discussed. Knowledge resource, latest research, findings and prospects presented in an accessible manner for researchers, students, eminent scientists, entrepreneurs, professionals and policy maker.

The study of pharmaceutical dosage forms has many connections to biological and medical sciences including physiology, biochemistry, pharmacology, pharmacotherapy, therapeutics, pharmacodynamics, pharmacokinetics, and pharmacognosy. Dictionary of Pharmaceutical Dosage Forms is a collection of terms and definitions prepared to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care. It can also provide reference material for hospital and medical staff, consultants, nursing instructors, and pharmaceutical science students. This first edition classifies and organizes the forms in an easily readable format, so readers will find it a quick and simple reference. Features Collects terms and definitions to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care Focuses on product dosage forms and includes supplementary information, providing readers, particularly pharmacy and medical students and professionals, insights into choices of dosage forms made during drug product development Offers information on the indications, contraindications, side effects, and more, for a given drug Classifies and organizes the forms in a readable format, providing a quick and simple reference

Ocimum species has been used as a traditional remedy for various ailments such as arthritis, bronchitis, cold, conjunctivitis, diarrhea, dysentery, and flatulence, as well as for healing wounds and lowering blood glucose level. These are characterized by variations in their morphology such as the shape, size and pigmentation of leaves, which cause differences in chemical composition and affect the commercial value of this genus. This book describes phytochemical investigations of Ocimum species using LC-MS/MS instruments to study qualitative and quantitative variations of phytochemicals in different Ocimum species. Features: Collection of Ayurvedic features and scientific analytical and pharmacological evidence of most important medicinal plants of genus Ocimum. Chemical signatures for the identification of Ocimum species. Easy-to-use analytical procedure for quality control of plants of Ocimum species and its herbal products.

Piper is the representative genus of family Piperaceae. Piper species are pan-tropical in distribution and found in both the hemispheres. As the king of all spices, black pepper, Piper nigrum, led to the global expeditions culminating in the discovery of India and the new world. Piper species have been reported to possess various pharmacological activities such as insecticidal, antibacterial, anti-inflammatory, antiplatelet, anti-hypertensive, antithyroid, antitumor activities and hepatoprotective properties. Botanical authentication of the plants of Piper species is difficult because of the morphological similarity among the species. This book describes ultra-performance liquid chromatography coupled with triple quadrupole electrospray tandem mass spectrometry in multiple reactions monitoring (MRM) mode to study the quantitative variation of thirteen bioactive markers in different plant parts of ten Piper species. Features: Collection of Ayurvedic features and scientific evidence of the most important medicinal plants of Piper species. Describes chemical signatures for identification of Piper species. Provides easy-to-use analytical procedure for quality control of Piper species and its products.

Biotechnology is a multidisciplinary field encompassing microbiology, bichemistry, genetics, molecular biology, chemistry, immunology, cell and tissue culture physiology. This book describes the recent developments in these areas. Current research topics such as Quorum sensing, Integrons, Phytomining are discussed, which would serve as an excellent reference work for both academicians and researchers in the field.

Biological and Pharmaceutical Applications of Nanomaterials presents the findings of cutting-edge research activities in the field of nanomaterials, with a particular emphasis on biological and pharmaceutical applications. Divided into four sections-nanomaterials for drug delivery, antimicrobial nanomaterials, nanomaterials in biosensors, and safety of nanomaterials-this book: Covers topics such as stimuli-responsive nanostructured silica matrixes, gold nanoparticles, and liposomes for targeting drug delivery and dental applications Describes the use of nanocarriers and nanoparticles as cancer and peptide therapeutics, the influence of surface characteristics on microbial adhesion, and the latest developments in antimicrobial nanostructured polymers for medical applications Discusses recent advances in nanodiagnostic techniques for infectious agents, chromogenic biosensors for pathogen detection, electrochemical biosensors for detecting DNA damage and genotoxicity, and molecular imaging with quantum dots including surface modifications by polymers for biosensing applications Featuring contributions from field experts and researchers in industry and academia, Biological and Pharmaceutical Applications of Nanomaterials provides state-of-the-art information on nanomaterials and their use in drug delivery, infection control, and biomedicine.

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.