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Modified Cyclodextrins for Chiral Separation offers a review of the latest advances in developing modified cyclodextrins as chiral selectors for various chromatographic and electromigration techniques. Over the years, many descriptions of chiral separation have appeared in academic journals and books, but most of them have been devoted to either the development of analytical methods and protocols or the summary of different chiral selectors, including cyclodextrins for chiral separation applications. This is in marked contrast to this volume which focuses on the research endeavors concerning the development of cyclodextrin derivatives specifically as either chiral mobile phases for capillary electrophoresis, or chiral stationary phases for various chromatographic techniques including gas chromatography, or high-performance liquid chromatography and supercritical fluid chromatography. The ongoing thread in this book is the synthesis of structurally-defined cyclodextrin derivatives and their applications in enantiomer separation by means of different analytical techniques. Modified Cyclodextrins for Chiral Separation is intended for those who are interested in expanding their knowledge of cyclodextrin chemistry and chiral separation, and in what cyclodextrin modification can be made to suit the needs of chiral selectors for different analytical techniques. It primarily focuses on the state-of-the-art cyclodextrin chemistry which is the basis for all chiral selectors used in these chiral separation techniques. Weihua Tang, PhD, is a professor at the Key Laboratory of Soft Chemistry and Functional Materials, Ministry of Education, Nanjing University of Science and Technology, China. Siu-Choon Ng, PhD, is a professor at the Division of Chemical and Biomedical Engineering, School of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore. Dongping Sun, PhD, is a professor at the Key Laboratory of Soft Chemistry and Functional Materials, Ministry of Education, Nanjing University of Science and Technology, China.
Microarrays play an increasingly significant role in drug discovery. The commercial landscape has changed dramatically over the past few years and researchers have made great advancements with regard to construction and use. Now in its second edition, Applying Genomic and Proteomic Microarray Technology in Drug Discovery highlights, describes, and evaluates current scientific research using microarray technology in genomic and proteomic applications.
Updated and revised to reflect recent progress in the field, the second edition discusses:
Unique to this edition is a new chapter on multiplex assays that examines the development and applications of arrays across diverse platforms. It discusses applications for qPCR, multiplex lateral flow, and multiplex bead assays. It also presents platform-to-platform comparisons.
Microarrays remain an invaluable tool for omics-based research not only in drug discovery, but in the life sciences, in clinical research, and for diagnostic applications worldwide. This volume presents the current state of the art on the utility of this technology to solve a host of important biological problems.
The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).
Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.
Enables readers to apply process dynamics and control theory to solve bioprocess and drug delivery problems The control of biological and drug delivery systems is critical to the health of millions of people worldwide. As a result, researchers in systems biology and drug delivery rely on process dynamics and control theory to build our knowledge of cell behavior and to develop more effective therapeutics, controlled release devices, and drug administration protocols to manage disease. Written by a leading expert and educator in the field, this text helps readers develop a deep understanding of process dynamics and control theory in order to analyze and solve a broad range of problems in bioprocess and drug delivery systems. For example, readers will learn how stability criteria can be used to gain new insights into the regulation of biological pathways and lung mechanics. They'll also learn how the concept of a time constant is used to capture the dynamics of diffusive processes. Readers will also master such topics as external disturbances, transfer functions, and input/output models with the support of the author's clear explanations, as well as: * Detailed examples from the biological sciences and novel drug delivery technologies *160 end-of-chapter problems with step-by-step solutions * Demonstrations of how computational software such as MATLAB and Mathematica solve complex drug delivery problems Control of Biological and Drug-Delivery Systems for Chemical, Biomedical, and Pharmaceutical Engineering is written primarily for undergraduate chemical and biomedical engineering students; however, it is also recommended for students and researchers in pharmaceutical engineering, process control, and systems biology. All readers will gain a new perspective on process dynamics and control theory that will enable them to develop new and better technologies and therapeutics to treat human disease.
A step-by-step, integrated approach for successful, FDA-approved
combination drug products
This authoritative and comprehensive book makes the reader familiar
with the processes of bringing orphan drugs to the global market.
There are between 5,000 and 7,000 rare diseases and the number of
patients suffering from them is estimated to be more than 50
million in the US and Europe. Before the orphan drug legislation
enacted in the US in 1983, there was a limited interest from
industry to develop treatment for very small patient groups. One of
the difficulties is, of course, that similar levels of investment
are needed from a pharmaceutical company to bring a drug to the
market for both small and large patient groups.
Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on:
Directing and carrying out specific tasks and courses of action
Making and communicating clear and achievable decisions
Solving problems on the spot
Managing the administrative aspects of chemical process development
The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into:
Understanding the workings of matrix organizations
Defining missions and creating action plans
Developing interdisciplinary approaches to problem solving
Holding review meetings, revising goals, and motivating staff
Prioritizing programs and responses to emergencies
In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studiesprovide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.
Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.
A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.
This book is an easy-to-read resource that complements current
regulatory guidance, by exploring key areas and practical
implications in greater detail. It is structured into chapters
encompassing a background to therapeutic risk management,
strategies for developing RMPs, implementation of RMPs, and the
continuing evolution of the risk management field.The topic is of
critical importance not only to the pharmaceutical and
biotechnology industries, but also regulators and healthcare
policymakers.Some chapters feature contributions from selected
A vast number of diagnostic and therapeutic decisions are based on measuring blood concentrations of molecules, yet most biochemical and pharmacological events actually take place in the tissues. Microdialysis is a key semi-invasive sampling technique to measure in vivo drug penetration to the target site in humans, the method being feasible in virtually every organ. Authored by international experts in this cutting edge field, this book will provide a comprehensive overview of microdialysis and its application for measuring drug distribution in drug development.
Clinical pharmacology plays an important role in today's medicine. Due to the high sensitivity, selectivity, and affordability of a mass spectrometer (MS), the high performance liquid chromatography - mass spectrometry (LC-MS) analytical technique is widely used in the determination of drugs in human biological matrixes for clinical pharmacology. Specifically, LC-MS is used to analyze: anticancer drugs antidementia drugs antidepressant drugs antiepileptic drugs antifundal drug antimicrobial drugs antipsychotic drugs antiretroviral drugs anxiolytic/hypnotic drugs cardiac drugs drugs for addiction immunosuppressant drugs mood stabilizer drugs This book will primarily cover the various methods of validation for LC-MS techniques and applications used in modern clinical pharmacology.
Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of herbal medicines. Identification and quantification of these chemical markers are crucial for quality control of herbal medicines. This book provides updated knowledge on methodology, quality assessment, toxicity analysis and medicinal values of natural compounds.
This book covers various aspects of antibody mediated drug delivery systems - theoretical aspects, processing, viral and non-viral vectors, and fields where these systems find and /or are being evaluated for applications as therapeutics and diagnostic treatment. Chapters discuss actual applications of techniques used for formulation and characterization. Applications areas include cancer, pulmonary, ocular diseases; brain drug delivery; and vaccine delivery. The contributing authors represent over 10 different countries, covering recent developments happening around the globe.
An informative look at the intricacies of today's drug development process
Once a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield.
This book covers both recent advances in the design and synthesis of new drugs, as well as the myriad other issues facing a new drug candidate as it moves through the development process. Utilizing recent case studies, the authors provide valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation.
Both novice and active researchers will appreciate the inclusion of chapters on such diverse topics as: Cross-coupling methods Asymmetric synthesis Automation Chemical Engineering Application of radioisotopes Final form selection Formulations Intellectual property
A wealth of real-world examples and contributions from leading process scientists, engineers, and related professionals make this book a valuable addition to the scientific literature.
The use of analytical sciences in the discovery, development and manufacture of pharmaceuticals is wide-ranging. From the analysis of minute amounts of complex biological materials to the quality control of the final dosage form, the use of analytical technology covers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drug development and manufacture, focusing on the analysis of the active ingredient or drug substance. It provides those joining the industry or other areas of pharmaceutical research with a source of reference to a broad range of techniques and their applications, allowing them to choose the most appropriate analytical technique for a particular purpose. The volume is directed at analytical chemists, industrial pharmacists, organic chemists, pharmaceutical chemists and biochemists.
This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.
"Controlled Release in Oral Drug Delivery" provides focus on specific topics, complementing other books in the initial CRS series. Each chapter sets the context for the inventions described and describe the latitude that the inventions allow. In order to provide some similar look to each chapter, the coverage includes the historical overview, candidate drugs, factors influencing design and development, formulation and manufacturing and delivery system design. This volume was written along three main sections: the relevant anatomy and physiology, a discussion on candidates for oral drug delivery and the major three groups of controlled release systems: diffusion control (swelling and inert matrices); environmental control (pH sensitive coatings, time control, enzymatic control, pressure control) and finally lipidic systems.
Pharmaceutical Chemistry: Therapeutic Aspects of Biomacromolecules offers a comprehensive and balanced introduction to this exciting and rapidly developing subject. Key strategies involved in the development and production of a range of clinically useful compounds are presented along with a broad overview of the way in which peptides, proteins, nucleic acids and carbohydrates are used therapeutically.
Illustrated with numerous examples, the book covers essential compounds and explains how they exert their influence through an understanding of biological processes. Pharmaceutical chemistry has become progressively more important in terms of both research and teaching, and this new book includes latest developments with examples carefully selected in order to emphasise the molecular basis of specific disease processes
The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug's safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected-numerical representations of biological information-are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.
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.
Regulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years. Research in Ayurveda is now a world-wide phenomenon, and several large pharmaceutical corporations are investing money for novel drug discovery from Ayurvedic sources. This book examines the regulatory and pharmacological aspects and includes extensive data on scientific evaluation carried out on Ayurvedic formulations. It will also serve as a reference book on standardization, pre-clinical studies, and clinical and toxicological studies on Ayurvedic formulations.
Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives-basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins and vaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens' genomes provides opportunities that never before have been available-identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated, replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process. The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies.
Biocatalysis is rapidly evolving into a key technology for the discovery and production of chemicals, especially in the pharmaceutical industry, where high yielding chemo-, regio-, and enantioselective reactions are critical. Taking the latest breakthroughs in genomics and proteomics into consideration, "Biocatalysis for the Pharmaceutical Industry" concisely yet comprehensively discusses the modern application of biocatalysis to drug discovery, development, and manufacturing. Written by a team of leading experts, the book offers deep insight into this cutting edge field.
Covers a wide range of topics in a systematic manner with an emphasis on industrial applicationsProvides a thorough introduction to the latest biocatalysts, modern expression hosts, state-of-the-art directed evolution, high throughput screening, and bioprocess engineeringAddresses frontier subjects such as emerging enzymes, metabolite profiling, combinatorial biosynthesis, metabolic engineering, and autonomous enzymes for the synthesis and development of chiral molecules, drug metabolites, and semi-synthetic medicinal compounds and natural product analogsHighlights the impact of biocatalysis on green chemistryContains numerous graphics to illustrate concepts and techniques
"Biocatalysis for the Pharmaceutical Industry" is an essential resource for scientists, engineers, and R&D policy makers in the fine chemical, pharmaceutical, and biotech industries. It is also an invaluable tool for academic researchers and advanced students of organic and materials synthesis, chemical biology, and medicinal chemistry.
Stroke remains one of the major causes of death and long-term disability worldwide. Currently, the only approved therapy for the acute treatment of this disease is thrombolysis, a strategy that can only be applied to a small percentage of patients due to its narrow therapeutic window. Unfortunately, during the last years numerous promising drugs that showed neuroprotection in the experimental setting failed to translate into the clinic because of their toxicity or lack of efficacy. Researchers in the field now face the crucial need to develop effective stroke therapies and successfully translate novel strategies into the clinical setting. Rational Basis for Clinical Translation in Stroke Therapy presents the most recent promising preclinical approaches and the most updated clinical evidence for treating stroke patients. By bringing together the experience of accomplished stroke researchers and clinicians, the book is a useful tool for improving the treatment and management of stroke patients. The book describes current approaches for the management of stroke patients including thrombolysis and mechanical recanalization procedures as well as other clinically relevant topics such as diagnosis, imaging, risk factors, and prevention. Also described are emerging interventions based on the use of stem cells, botulinum toxin, and antidepressants which complement emergency stroke treatment and conventional rehabilitation procedures. Clinical approaches are integrated with the most promising therapeutic opportunities based on targeting the immune system, hypothermia, and postconditioning. The book also covers issues related to the improvement of R&D strategies in stroke therapeutics, aimed at the implementation of preclinical approaches with stroke model guidelines and at the optimization of clinical trial design. This volume is a reference for all those interested in the rational development of novel stroke therapeutics.
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