By guiding in the application of techniques and tools for predicting ADMET outcomes in drug candidates, Predictive ADMET offers a road map for drug discovery scientists to generate effective and safe drugs for unmet medical needs. Featuring case studies and lessons learned from real drug discovery and development, the text: helps users diagnose ADMET problems; presents appropriate recommendations; introduces the current clinical practice for drug discovery and development; and consolidates the tools and models to intelligently integrate existing in silico, in vitro and in vivo ADMET data.

Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to come, the Third Edition will offer completely new entries that cover critical issues in the field such as the impact of genomics, biotechnology, and implants on drug discovery, targeting, delivery, and formulation. In addition, it will address new regulatory issues, such as the changes in advertising regulations, and emerging FDA procedures.

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.

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.

The neurosciences have been an especially difficult field for drug discovery. Because of the huge complexity of the nervous system and poor understanding of most psychiatric and neurological diseases, most drugs currently available are the result of chance observations rather than a truly comprehensive approach. However, this situation has begun to change. Enormous progress in molecular biology has yielded breakthrough discoveries of the causes of nervous system diseases, opening the door for better-targeted and entirely novel therapies.
Reflecting these recent advances, Drug Discovery for Nervous System Diseases presents the latest techniques and approaches for drug discovery, organizing them according to diseases rather than classes of drugs or drug targets, as past books have done. Written with optimistic anticipation of great progress still to come, this text provides both a guide to present realities and a look to future possibilities in this burgeoning field.
Coverage in Drug Discovery for Nervous System Diseases includes:
* Fundamentals of drug discovery-receptors, target selection, and drug development
* Schizophrenia
* Depression
* Anxiety disorders
* Alzheimer's disease
* Parkinson's disease
* Ischemic stroke, brain, and spinal cord injury
* Other neurodegenerative diseases
* Sleep disorders
* Epilepsy
* Pain
This practical handbook features a uniform presentation for each chapter, with a brief description of existing drugs leading to recent molecular biological and genetic findings, translational research and the interface to clinical trials, and finally an outlook on future drug targets. Rich illustrations-schematic diagrams and tables-provide a dynamic visual experience throughout the text.
A unique and up-to-date guide to a field currently undergoing a major growth spurt, Drug Discovery for Nervous System Diseases offers both practitioners and advanced students an unparalleled resource.

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

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. "

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.

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.

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.

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 two presents: * Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. * A comprehensive chapter on pharmaceutical water systems. * A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. * A detailed chapter on processing of parenteral drug products (SVPs and LVPs). * Presentations on widely used sterilization technologies - steam, gas / chemical, radiation, filtration and dry heat. * An in-depth chapter on lyophilization.

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.

This book summarizes experimentally-supported research on the therapeutic efficacy of plant extracts and their constituents on a range of respiratory diseases including infections. It discusses the pharmacological, cellular and molecular factors involved in the pathogenies of respiratory diseases and their modulation by plant-derived compounds. Additionally, it underlines the growing relevance of medicinal plant-based advanced drug delivery systems for treating lung diseases providing maximal therapeutic efficacy with better patient compliance. Overall, this comprehensive book is a blend of translational, biological, chemical and drug delivery aspects of medicinal plants employed in targeting respiratory diseases and attracts a range of audiences including physiochemist, translational and clinical researchers working in the field of respiratory diseases.

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.

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":

The first edition of this now classic work helped to establish mass spectrometry as the premier tool for drug metabolism studies. Completely rewritten from start to finish, Using Mass Spectrometry for Drug Metabolism Studies, Second Edition brings medicinal chemists and mass spectrometry professionals up to speed with the rapid advances in the field, the emergence of cutting-edge approaches, and ways to meet steadily increasing vendor demands. Written by international scientists who are experts in their respective disciplines, this state-of-the-art reference effectively encapsulates current mass spectrometry best practices. The stand-alone chapters cover various topics - from metabolite identification to fast chromatography with UPLC - and in a style that is understandable to experts and field newcomers alike. The second edition of this bestseller includes coverage of new instrumentation and software as well as a wealth of updated information on the latest findings surrounding biomarkers and metabolomics and new chapters on both UPLC and DESI/DART. With more than 180 illustrations and an eight-page color insert, this valuable reference explores multiple modern mass spectrometry techniques and strategies. It includes an excellent overview of the entire drug discovery process plus the latest developments on how mass spectrometry is used to support this endeavor.

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.

A True Insider's Guide to the Field - Then and Now Until now, there has not been a book that effectively addresses the historical basis of protein discovery. Featuring contributions from a distinguished international panel of experts, Protein Discovery Technologies elucidates the principles, techniques, strategies, and broad range of applications of protein discovery by documenting the often untold stories and personal accounts of the contributors' past scientific achievements. Incorporates Short, Personal Discovery Vignettes Rather than an exhaustive field analysis, this globally pertinent resource presents in-depth discussions of various methods for protein discovery, including bioinformatics, interaction cloning, protein purification, phage display, non-primate models, and chemical targeting. It also explores biological themes through the examination of cell death, angiogenesis, hemostasis, development, signal transduction, transcriptional control, cell cycle control, neurobiology, and quality control. This readily accessible resource discusses an array of interesting topics, including: Tumor necrosis factors The origin of interferon as an angiogenesis inhibitor In vivo combinatorial mapping of vascular zip codes Extracellular matrix degradome as regulators of angiogenesis and tumor growth A matricellular protein prototype The use of RING finger proteins as E3 Ubiquitin Ligases Whereas most books tend to be more specialized, this book contains a broad view of the protein discoveries in many different fields, making Protein Discovery Technologies a valuable reference for today's researchers, both the new and more seasoned, who are seeking a newfound perspective or a deeper understanding of this exciting field.

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

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

• advances in international regulatory requirements, including ICH guidelines and harmonization
• a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
• the latest regulatory requirements for expediting new drug approvals
• strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

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

This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current with the basic sciences, systems, applications, and advances in drug development from materials used in formulations and dosage form design and manufacture, to testing in clinical trials.
Improve research and development strategies with brand new content on:
methods of in vivo imaging of dosage forms
excipients, tablets, and aerosols from physical chemistry to dosage form
solid state drug delivery
biotechnology-based pharmaceuticals
modern evaluation techniques for medicinal products
pharmaceutical nanotechnology
pharmaceutical physics
pediatric and geriatric medication
routes of administration
paradigms in pharmaceutical research"