The aim and scope of this book is to highlight the sources, isolation, characterization and applications of bioactive compounds from the marine environment and to discuss how marine bioactive compounds represent a major market application in food and other industries. It discusses sustainable marine resources of macroalgal origin and gives examples of bioactive compounds isolated from these and other resources, including marine by-product and fisheries waste streams. In addition, it looks at the importance of correct taxonomic characterization.

The gold standard for industrial research now completely revised in line with current trends in the field, with all contributions extensively updated or rewritten.
In 21 chapters readers can benefit from the key working knowledge of today's leading pharmaceutical companies, including Pfizer, AstraZeneca, and Roche. Drug developers from industry and academia present all the factors governing drug bioavailability, complete with practical examples and real-life data.
Part I focuses on in vitro and in vivo measurements of physicochemical properties, such as membrane permeability and ionization. Part II discusses solubility and gastrointestinal absorption, while the third part is devoted to metabolism and excretory mechanisms. The much revised and expanded part IV surveys current in silico approaches to predict drug properties needed to estimate the bioavailability of any new drug candidate. The final part shows how poor bioavailability may be improved by various approaches during the development process.
No other publication offers the same level of treatment on this crucial topic in modern drug development.

This title includes a number of Open Access chapters. Pharmaceutical technology deals with the discovery, production, processing, and safe and effective delivery of medications to patients. Technologies involved include computer modeling for research, bioengineering for research instrumentation, processes and methods for increasing production, and computing technology and biosystematics for the management and analysis of data. This new book covers a wide range of important topics on today's pharmaceutical technology, such as in vitro drug release and controlled drug delivery, the use of nanotechnology in pharmaceuticals, quantum dot imaging, assessment and efficacy of pharmaceuticals, and much more.

Finally - a book that covers all aspects of the illicit use of cocaine, amphetamines, ecstasy and/or designer drugs such as GHB, written by two experts in their field. The use of these drugs remains a continuous threat in health and medical care delivery, and this book will be an essential asset to the physician who may have to face the evaluation of patients whose use of these drugs compromises an effective treatment plan for other health issues.

The book has been conceived to fill the void in existing physician reference materials, and provides a comprehensive review of the theoretical knowledge and scope of pharmacotherapy in individuals who are hooked on a psychoactive substance.

While detailed scientific information is obtainable in other major articles, the book's straightforward format and style, along with its illustrations, will make for easy reading as emphasis is put on information specifically related to drugs that occur most abused in today s society. The information provided is based on clinical practice rather than pure experimental data, which will give the physician more effective tools useful in their daily practice. Many mechanisms of action of abuse are described in detail and references are provided to direct the reader to further sources for additional information.

As a special feature, the book incorporates uncluttered tables and charts, which result in immediate clarification of the mode of action on the central nervous system and the reason for misuse, thus avoiding usual long and fatiguing text in common reference books. The book aims to give the reader a clear and concise plan on what to do when being faced with an overdose situation.

A well-organized Table of Contents rapidly leads the reader from general pharmacological issues to the specific overdose syndrome and its management. Additionally, significant emphasis is placed on the practical do's and don ts for physicians, with special reference to the predictive signs of aberrant drug-related behavior and the identification of the drug diverter by using urine drug screening. "

Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances-leaving implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory. Dietary Supplement GMP provides: a practical guide in easy to understand language to help navigate through the requirements for systems covering process and quality control suggestions and practical recommendations on "how-to" achieve full compliance explanation of the FDA's role regarding inspection, enforcement, recall/seizure of products and prosecution Dietary Supplement Good Manufacturing Practices (GMP) covers: Personnel Plants and Grounds Equipment and Utensils Sanitation of Buildings and Equipment Quality Assurance and Laboratory Operations The Quality Control Unit Production and Process Controls

Recent advances in immunology and biology have opened new horizons in cancer therapy, included in the expanding array of cancer treatment options, which are immunotherapies, or cancer vaccines, for both solid and blood borne cancers. Cancer Vaccines: Challenges and Opportunities in Translation is the first text in the field to bring immunotherapy treatments from the laboratory trial to the bedside for the practicing oncologist. Cancer Vaccines: Challenges and Opportunities in Translation: * Critically analyzes the most promising classes of investigational immunotherapies, integrating their scientific rationale and clinical potential * Discusses "theranostics" as pertaining to immunotherapy, i.e., using molecular diagnostics to identify patients that would most likely benefit from a therapy * Presents the new paradigm of biomarker guided R&D and clinical development in immunotherapy of cancer * Reviews bottlenecks in translational process of immunotherapies and offers strategies to resolve them

Nanoengineered Biomaterials for Advanced Drug Delivery explores the latest advances in the applications of nanoengineered biomaterials in drug delivery systems. The book covers a wide range of biomaterials and nanotechnology techniques that have been used for the delivery of different biological molecules and drugs in the human body. It is an important resource for biomaterials scientists and engineers working in biomedicine and those wanting to learn more on how nanoengineered biomaterials are being used to enhance drug delivery for a variety of diseases. Nanoengineered biomaterials have enhanced properties that make them more effective than conventional biomaterials as both drug delivery agents, and in the creation of new drug delivery systems. As nanoengineering becomes more cost-effective, nanoengineered biomaterials have become more widely used within biomedicine.

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

The authors show how the pharmaceutical industry faces the development of dermal drugs and provide the only book of its kind that describes how the industry develops and selects dermal drugs, complete with the challenges and opportunities of the field. Delivery of drugs through the skin has been an attractive and challenging area for research, and advances in modern technologies have resulted in a larger number of drugs being delivered transdermally, including conventional hydrophobic small molecule drugs, hydrophilic drugs and macromolecules. Offering the perspective from the industrial side of selection and development of drugs, the primary audience is geared towards the pharmaceutical industry but can also offer valuable information to clinicians, compounding pharmacists, and similarly pharmacy students. Dermal Drug Selection and Development covers the scientific gaps that exist in terms of dermal pharmacokinetics and the resulting uncertainty by clinicians when choosing a drug candidate.

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume three presents: * An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. * Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing. * Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems. * New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

Encyclopedia of Dietary Supplements presents peer-reviewed, objective entries that rigorously examine the most significant scientific research on basic chemical, preclinical, and clinical data. Designed for healthcare professionals, researchers, and health-conscious consumers, it presents evidence-based information on the major vitamin and mineral micronutrients, herbs, botanicals, phytochemicals, and other bioactive preparations. Supplements covered include: Vitamins, beta-carotene, niacin, and folate Omega-3 and omega-6 fatty acids, isoflavones, and quercetin Calcium, copper, iron, and phosphorus 5-hydroxytryptophan, glutamine, and L-arginine St. John's Wort, ginkgo biloba, green tea, kava, and noni Androstenedione, DHEA, and melatonin Coenzyme Q10 and S-adenosylmethionine Shiitake, maitake, reishi, and cordiceps With nearly 100 entries contributed by renowned subject-specific experts, the book serves as a scientific checkpoint for the many OTC supplements carried in today's nutritional products marketplace. Also Available OnlineThis Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367; (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]

Advances in genomics and combinatorial chemistry during the past two decades inspired innovative technologies and changes in the discovery and pre-clinical development paradigm with the goal of accelerating the process of bringing therapeutic drugs to market. Written by William Kisaalita, one of the foremost experts in this field, 3D Cell-Based Biosensors in Drug Discovery Programs: Microtissue Engineering for High Throughput Screening provides the latest information - from theory to practice - on challenges and opportunities for incorporating 3D cell-based biosensors or assays in drug discovery programs. The book supplies a historical perspective and defines the problem 3D cultures can solve. It also discusses how genomics and combinatorial chemistry have changed the way drug are discovered and presents data from the literature to underscore the less-than-desirable pharmaceutical industry performance under the new paradigm. The author uses results from his lab and those of other investigators to show how 3D micro environments create cell culture models that more closely reflect normal in vivo-like cell morphology and function. He makes a case for validated biomarkers for three-dimensionality in vitro and discusses the advantages and disadvantages of promising tools in the search of these biomarkers. The book concludes with case studies of drugs that were abandoned late in the discovery process, which would have been discarded early if tested with 3D cultures. Dr. Kisaalita presents evidence in support of embracing 3D cell-based systems for widespread use in drug discovery programs. He goes to the root of the issue, establishing the 3D cell-based biosensor physiological relevance by comparing 2D and 3D culture from genomic to functional levels. He then assembles the bioengineering principles behind successful 3D cell-based biosensor systems. Kisaalita also addresses the challenges and opportunities for incorporating 3D cell-based biosensors or cultures in current discovery and pre-clinical development programs. This book makes the case for widespread adoption of 3D cell-based systems, rendering their 2D counterparts, in the words of Dr. Kisaalita "quaint, if not archaic" in the near future.

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.

With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary.

Grounded in practicality, the book s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

Through the use of practical examples and solutions, this timely "Fifth Edition "has been updated and expanded to provide the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly clinical trials and bioequivalence studies.

New to the "Fifth Edition":

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery.

With extensively updated content and 21 new chapters, this text examines:

• quality and efficiency of drug target validation and potential drug compound selection
• reducing assay costs and improvement in assay technology
• data quality improvement
• trends in drug discovery
• how drug screening can minimize adverse drug effects
• recent advancements, including: high content screening; protein-protein interactions; high-throughput crystallization; lead optimization; chemoinformatics and microfluidics technologies; target validation by genomics, proteomics, and siRNA; structure-based drug design; automation; and medicinal chemistry

Volume 2 discusses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. In addition, it describes the impact of the shift to personalized medicines in the fields of pharmaceutical biotechnology, pharmacogenomics, and nanotechnology.
DELIVERY OF DRUGS BY THE PULMONARY ROUTE - Covers the interaction between the physical chemistry of the formulations and administered particles with the anatomy of the bronchial and alveolar regions
PEDIATRIC AND GERIATRIC PHARMACEUTICS - Addresses the physiological changes, design, and production of formulations for each of these patient populations
BIOEQUIVALENCE EVALUATION - Covers how to measure the bioequivalence of the same drug in quick-release tablet, capsule, or sustained-release form, as well as branded and generic systems
TARGET-ORIENTED DELIVERY SYSTEMS - Explores the challenges of designing delivery systems that target specific sites in the body and cause fewer side effects through interaction with non-diseased tissues

In recent years, high-density DNA microarrays have revolutionized biomedical research and drug discovery efforts by the pharmaceutical industry. Their efficacy in identifying and prioritizing drug targets based on their ability to confirm a large number of gene expression measurements in parallel has become a key element in drug discovery. Microarray Innovations: Technology and Experimentation examines the incredibly powerful nature of array technology and the ways in which it can be applied to understanding the genomic basis of disease. Explores a myriad of applications in use today This volume explores recent innovations in the microarray field and tracks the evolution of the major platforms currently used. The international panel of contributors presents a survey of the past five years' research and advancements in microarray methods and applications and their usage in drug discovery and biomedical research. The contributions discuss improvements in automation (array fabrication and hybridization), new substrates for printing arrays, platform comparisons and contrasts, experimental design, and data normalization and mining schemes. They also review epigenomic array studies, electronic microarrays, comparative genomic hybridization, microRNA arrays, and mutational analyzes. In addition, the book provides coverage of important clinical diagnostic arrays, protein arrays, and neuroscience applications. Examines improved methodologies As microarrays have evolved steadily over time from archetypical in-house complementary DNA (cDNA) arrays to robust commercial oligonucleotide platforms, there has been a migration to higher density biochips with increasing content and better analytical methodologies. This compendium summarizes the vast advances that have been made in this technology, highlighting the supreme advantages of microarray-based approaches in the field of biomedical research.

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New chapters cover:

• the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
• pharmacovigilance programs designed to prevent widespread safety issues
• legal issues surrounding the sourcing of foreign APIs
• the issues of counterfeit drugs
• updates on quality standards

High throughput analysis plays a critical role in the pharmaceutical industry. The ever-shortening timelines and high costs of drug discovery and development have brought about the need for high throughput approaches to methods that are currently used in the industry. Written and edited by well-known contributors who remain active in this line of research, this book systematically describes high throughput analysis for the pharmaceutical industry, including advanced instrumentation and automated sample preparation. The text discusses various techniques, including HPLC, MALDI-MS, and LC-MS/MS methods, with an emphasis on the later stage of drug development, including pharmacokinetics.

An ever-increasing demand for better drugs, elevated safety standards, and economic considerations have all led to a dramatic paradigm shift in the way that drugs are being discovered and developed. Known as rational drug design, this contemporary process is defined by three main steps: the discovery of lead compounds, surgical manipulation to develop pharmacophores, and further optimization to produce the best compounds. Chemistry and Molecular Aspects of Drug Design and Action brings together an impressive collection of world-renowned pharmacochemistry scientists who are currently defining the emergence of rational drug design. Offering insight from their own specialized research, these pioneers highlight the variety of approaches being employed in this field, including those that start by considering either molecular mechanisms of drug action, or the metabolizing enzyme action occurring in the structure of a drug molecule. Another approach they explore is one that starts from the pathobiochemistry and pathophysiology of target diseases. Furthermore, the book also considers drug development that makes use of already developed compounds stored in data banks. Divided into five parts, each dedicated to various aspects of the classical medicinal chemistry approach, the text makes it easy for readers to focus on a field of specific interest. Chemical, Biochemical, and Biological Aspects of Pathophysiological Conditions Classical Medicinal Chemistry Drug Design, Chemical and Molecular Aspects of Drug Action Drug Xenobiotic Metabolism Physical Organic and Theoretical Medicinal Chemistry While each section can be studied independently, the combined material in this volume provides the most comprehensive overview available on rational drug design. This work is an invaluable resource both for those entering the field, as well as those researchers looking to b

This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines Uses case studies to help readers understand and apply ICH guidelines Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.