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The success of any drug discovery project relies upon the quality
of the lead that initiates the lead optimization process. What
defines a quality lead, where these quality leads come from and how
one discovers them has been the subject of intense debate within
the pharmaceutical industry, relies upon defining those properties
that historically have led to successful drug discovery. This
volume addresses these questions and specifically discusses
diabetes, obesity and tuberculosis.
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
This Second Edition of the classic handbook details how to set up an HPLC system that capitalizes on the latest innovations. It covers new techniques in high-temperature, micro-flow, and ultra-fast chromatography, the linking of an HPLC to a mass spectrometer, and more. Complete with a CD-ROM and appendices, this guide has everything chromatographers need to know to confidently separate, identify, purify, and quantify compounds.
Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.
Building on the success of the previous editions, the Textbook of Drug Design and Discovery, Fifth Edition, has been thoroughly revised and updated to provide a complete source of information on all facets of drug design and discovery for students of chemistry, pharmacy, pharmacology, biochemistry, and medicine. The information is presented in an up-to-date review form with an underlying and fundamental focus on the educational aspects. Beginning with an introduction to drug design and discovery, the first eight chapters cover molecular recognition, ligand-based drug design, and biostructure-based drug design. The authors also discuss drug-like properties and decision making in medicinal chemistry, chemical biology, natural products in drug discovery, and in vivo imaging in drug discovery. The middle six chapters provide an overview of peptide and protein drug design, prodrugs in drug design and development, and enzyme inhibitors. The authors also go through receptors (structure, function, and pharmacology), ion channels (structure and function), and neurotransmitter transporters (structure, function, and drug binding). The following chapters address important neurotransmitter systems, GABA and glutamic acid receptors and transporter ligands, acetylcholine, histamine, dopamine and serotonin, and opioid and cannabinoid receptors. The book concludes with an examination of neglected diseases, anticancer agents, tyrosine kinase receptors, and antibiotics.
Following the success of the first edition, this book is designed to provide practical and timely information for toxicologic pathologists working in pharmaceutical drug discovery and development. The majority of the book (Organ Systems) will provide detailed descriptions of histopathological lesions observed in drug development. In addition, it will provide information to assist the pathologist in making determinations of the origin of lesions as well as its relevance to human risk. Toxicologic Pathology: Nonclinical Safety Assessment, Second Edition includes 2 new concept chapters. The first of the new chapters address approaches for the evaluation of unique therapeutic modalities such as cell therapies, gene therapies, and gene expression knockdown therapies. While these still represent new developing therapeutic approaches, there has been significant experience with the therapeutic modalities in the last 5 years. The second new chapter addresses the nonclinical safety assessment of medical devices, a topic of increasing importance that was not addressed in a unique chapter in the first edition. The other concept chapters have been updated and cover important topics including the overview of drug development; principles of nonclinical safety assessment; an introduction to toxicologic pathology; techniques used in toxicologic pathology, clinical pathology, toxicokinetics, and drug development toxicogenomics; and spontaneous lesions. The 13 organ system chapters provide the specifics related to pathologic characteristics, differential diagnosis, and interpretation of toxic responses in each organ system. These chapters are specifically important for the bench pathologist but also for the toxicologist who interacts with pathologists and function as study toxicologists and project team representatives in the drug development arena.
An increasing number of pharmaceuticals in human and veterinary
medicine are being developed using advanced genetic and other
methods that focus on modification of somatic and embryonic cells.
These methods, in the setting of drug manufacture, call for new
processes that go beyond the traditional unit processes of chemical
and biological production, such as batch submerged culture.
This book is the first to describe in detail these advanced
biological processes and show how they are applied to the
production of biopharmaceuticals, from product generation and
purification to fill-finish operations.
The work explains how technologies developed in the last decade function similarly to unit operations for producing advanced biopharmaceuticals, such as hormones, cytokines, therapeutic enzymes, modified proteins, and transgenic products - to name a few. From large-scale animal cell bioreactors to patient-customized products, this volume describes the effects of new technologies on biopharmaceutical processes and guides users on how to apply new technologies in process 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.
An integrated and insightful look at successful drug synthesis in today's drug discovery market
The pharmaceutical industry is unquestionably vibrant today, with drug synthesis making a vital contribution. Whether in the early developmental stages of identifying and optimizing a lead, or the latter stages of process development and cost-effective scale-up, the ability to design elegant and economical synthetic routes is often a major factor in the eventual viability and commercial success of a drug.
"Contemporary Drug Synthesis" examines how leading researchers and manufacturers have integrated chemistry, biology, pharmacokinetics, and a host of other disciplines in the creation and development of leading drugs.
Authored by four of the pharmaceutical industry's most respected scientists, this timely volume:
This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,926 medicinal plants, collected from 5,535 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.
Teaches proper procedures for using tools and analytical methods in
a regulated lab setting
Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes: Method validation of potency, related substances, and dissolution testing Validation for pharmaceutical excipients, heavy metals, and bioanalysis Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters The LCMS system calibration Proper environmental chamber qualification Entire qualification process for computer equipment, hardware, and software Validation of Excel spreadsheets Regulatory requirements of the FDA, ICH, Europe, and Japan
Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.
Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibrationscientists, and research and development scientists.
Research and development of medicines is one of our most challenging, stimulating and successful industrial activities and this book sets out to interest those seeking information about different careers in and associated with the pharmaceutical industry.
Since publication of the 1st edition of this book there have been many changes in the environment of medicines research; changes in philosophy, direction, organisation, communication, financing and regulation, reflected here in the updated and additional chapters. The mapping of the human genome, the growth of information technology and the globalisation of medicines research and development to international standards are just some of the changes which have a major impact on the way we perceive and address discovery research, development and the marketing needs of medicines.
In addition, as with many other industries, the concept of job for life has been replaced by the need to acquire transferable skills through continuing education and training. For those already in the industry, this book will help maintain a clear focus for career development opportunities in the light of the current structure.
While it is not possible to cover all the variants of jobs and opportunities that exist in such a complex industry, it is hoped that enough light is thrown on the different careers in pharmaceuticals to allow those at the start of their working life as well as those seeking a new direction in their career to make the right choice.
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. "
Bioprocess Engineering for a Green Environment examines numerous bioprocesses that are crucial to our day-to-day life, specifically the major issues surrounding the production of energy relating to biofuels and waste management. The nuance of this discussion is reflected by the text's chapter breakdown, providing the reader with a fulsome investigation of the energy sector; the importance of third-generation fuels; and the application of micro- and macroalgae for the production of biofuels. The book also provides a detailed exploration of biocatalysts and their application to the food industry; bioplastics production; conversion of agrowaste into polysaccharides; as well as the importance of biotechnology in bio-processing. Numerous industries discharge massive amounts of effluents into our rivers, seas, and air systems. As such, two chapters are dedicated to the treatment of various pollutants through biological operation with hopes of achieving a cleaner, greener, environment. This book represents the most comprehensive study of bioprocessing-and its various applications to the environment-available on the market today. It was furthermore written with various researchers in mind, ranging from undergraduate and graduate students looking to enhance their knowledge of the topics presented to scholars and engineers interested in the bioprocessing field, as well as members of industry and policy-makers. Provides a comprehensive overview of bioprocesses that apply to day-to-day living. Is learner-centered, providing detailed diagrams for easy understanding. Explores the importance of biocatalysts and their applications to the food industry, as well as bioplastics production. Examines the unique capabilities of bioprocess engineering and its ability to treat various pollutants. .
Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies.
This monograph is devoted to different aspects associated with citric acid, inorganic citrates and their aqueous and organic solutions. It includes information about properties, occurrence and technological applications of citric acid and inorganic citrates. Phase equilibria - melting, freezing, boiling, vapour pressures, solubilities of citric acid in water, organic solvents and ternary systems are presented, correlated, and analyzed. Dynamic properties - viscosities, diffusion coefficients, electrical conductivities and surface tensions are examined. Mathematical representations of citric acid dissociation, in electrolyte solutions and in buffers are discussed. Citric acid chemistry - syntheses of citric acid, neutralization, degradation, oxidation, esterification, formation of anhydrides, amides and citrate-based siderophores is reviewed.
There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as ‘working tools’ within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:
"Hills is probably the best person I can think of to write this book. He has the deepest background combined with considerable experience in solving problems with food." —R. G. Bryant, University of Virginia.
Food scientists have many excellent tools at their disposal with which to study food at both the micro- and macrostructural levels. But, when it comes to analyzing dynamic structural changes in food during processing and storage, none can compare with magnetic resonance imaging (MRI). Still a very young approach, MRI food imaging has contributed greatly to recent advances in food science, and promises to yield much more valuable information in the years ahead. Written by a leading pioneer in the field, Magnetic Resonance Imaging in Food Science covers the latest in MRI food imaging theory and practice.
Written primarily for food scientists and engineers, the book offers a practical, unified approach to the subject. Material is organized in three main parts corresponding to the distances of scale probed by MRI studies—namely, the macroscopic, microscopic, and macromolecular. Throughout, the emphasis is on ways in which studies of food undergoing processes can be modeled using the equations of heat, mass, and momentum transport, and how those models can be used in process design optimization programs.
Magnetic Resonance Imaging in Food Science provides researchers with the most up-to-date, detailed coverage of:
Magnetic Resonance Imaging in Food Science is an important working resource for all researchers engaged in the never-ending struggle to produce safer, higher-quality foods more efficiently.
This volume presents recent developments in the novel drug development and potential of extremophilic cyanobacteria. It discusses how these tiny organism originated, produce oxygen that leads to evolution of life on the earth, how their survival strategies in extreme climatic conditions lead to diverse metabolic pathways, and the opportunity to use them to develop novel drugs. The book is comprised of five chapters, starting with the origin of cyanobacteria, their survival strategies under extreme conditions, and their capabilities to change metabolic activities.The second chapter explores the different metabolic pathways found in cyanobacteria and examines advances in this field and recent techniques like MALDI-TOF imaging and metagenomics tools as well as in silico techniques for rapid screening of secondary metabolites. Further chapters cover the glycomics of cyanobacteria, anticancer drug development, and some issues and challenges of using cyanobacteria to develop drugs. Extremophilic Cyanobacteria For Novel Drug Development provides insight into future perspectives in drug development and is a key resource for students, researchers and professionals in pharmacy, medicinal chemistry, pharmacognosy biotechnology, biology, and academics.
Volume III of this manual provides an overview of the analytical investigation of 23 additional Chinese Herbal Drugs, which are most commonly used in Traditional Chinese Medicine. Together with Volumes I and II this current volume represents the most comprehensive overview to analytical studies of those herbal drugs. The quality proof of the investigation meets the standard of the European Drug Regulatory Authority. The authors refer to the bioactive constituents, pharmacological and biological activities of all single herbal drugs, as well as their therapeutic applications. Analytical methods applied are described in detail.
The first comprehensive book on the biology and ecology of pharmaceutical echinoderms. Contributed by scientists of both marine biology and pharmacy disciplines. All reported echinoderm species producing secondary metabolites are dealt with. Having previously only been known as nutritional invertebrates, a book exploring the contribution of the echinoderms as sources of secondary metabolites for therapeutic compounds is timely. All 200+ images are produced in full color, providing a high-quality reference. This book provides the taxonomy, common name, global distribution, habitat, diagnostic features and pharmaceutical compounds (along with their activities) of 150 species of ecinoderms along with over 200 detailed illustrations in glorious color. Among the biota of marine habitats, the echinoderms, which include sea stars (starfish), brittle stars and basket stars, sea urchins and sand dollars, sea cucumbers, and sea lilies or feather stars, are known for their importance as promising sources of bioactive compounds for development of pharmaceuticals. Their potential therapeutic applications have been growing rapidly in the treatment of many diseases.
There is a dramatic rise of novel drug use due to the increased popularity of so-called designer drugs. These synthetic drugs can be illegal in some countries, but legal in others and novel compounds unknown to drug chemistry emerge monthly. This thoughtfully constructed edited reference presents the main chromatographic methodologies and strategies used to discover and analyze novel designer drugs contained in diverse biological materials. The methods are based on molecular characteristics of the drugs belonging to each individual class of compounds, so it will be clear how the current methods are adaptable to future new drugs that appear in the market.
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explains the how and why of various GTI control tactics and practices Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing Includes real-life examples of GTI control in drug substance and drug product development processes Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of-and a current framework for-GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.
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