Highlighting 15 selected chiral structures, which represent candidate or marketed drugs, and their chemical syntheses, the authors acquaint the reader with the fascinating achievements of synthetic and medicinal chemistry.

The book starts with an introduction treating the discovery and development of a new drug entity. Each of the 15 subsequent chapters presents one of the target structures and begins with a description of its biological profile as well as any known molecular mechanisms of action, underlining the importance of its structural and stereochemical features. This section is followed by detailed discussions of synthetic approaches to the chiral target structure, highlighting creative ideas, the scaling-up of laboratory methods and their replacement by efficient modern technologies for large-scale production. Nearly 60 synthetic reactions, most of them stereoselective, catalytic or biocatalytic, as well as chiral separating methodologies are included in the book.

Vitomir Sunjic and Michael J. Parnham provide an invaluable source of information for scientists in academia and the pharmaceutical industry who are actively engaged in the interdisciplinary development of new drugs, as well as for advanced students in chemistry and related fields.

Insights and analysis that challenge current thought on consumer branding theory and strategy Pharmaceutical companies need to go beyond simply relying on strong sales forces and innovative research and development to succeed. Effective branding strategy is essential. PharmaceuticalsWhere's the Brand Logic?: Branding Lessons and Strategy discusses in detail the application of current consumer branding theory to pharmaceutical marketing. This comprehensive book pulls information from fast moving consumer goods (FMCG) research and brand theory and applies it to the pharmaceutical world. It looks at branding on multiple levels within the pharmaceutical industry, including the industry brand, the corporate brand, the franchise brand, and the global and local product brand. Practical strategies are extensively explained and future challenges facing the pharmaceutical industry are explored, all geared to help any pharmaceutical professional to successfully market his or her brand. PharmaceuticalsWhere's the Brand Logic?: Branding Lessons and Strategy may well become a daily reference for anyone in the industry, providing in a single volume a framework for the organization of a brand portfolio for any pharmaceutical company. This unique resource challenges traditional thought about the concept of branding in the pharmaceutical industry, examining several of the most difficult branding theory issues. This helpful guide provides several figures to fully explain data. Topics in PharmaceuticalsWhere's the Brand Logic?: Branding Lessons and Strategy include: what is branding how is branding applied to the FMCG and pharmaceutical industries corporate brandsand how they can be leveraged franchise branding as a business strategy developing and sustaining pharmaceutical brands over time saving the credibility of the pharmaceutical industry changing the pharmaceutical business model to use branding as a strategic tool much, much more PharmaceuticalsWhere's the Brand Logic?: Branding Lessons and Strategy provides the information and tools to help gain the competitive edge in a tough marketplace. This is an invaluable resource for anyone in the global pharmaceutical industry, including marketing personnel, senior management, general managers, strategy groups, and training departments.

Recent analyses of drug attrition rates reveal that a significant number of drug candidates fail in the later stage of clinical development owing to absorption, distribution, metabolism, elimination (ADME), and toxicity issues. Lead optimization in drug discovery, a process attempting to uncover and correct these defects of drug candidates, is highly beneficial in lowering the cost and time to develop therapeutic drugs by reducing drug candidate failures in development. At present, parallel synthesis combining with high-throughput screening has made it easier to generate highly potent compounds (i. e. , hits). However, to be a potential drug, a hit must have drug-like characteristics in addition to potency, which include optimal physicochemical properties, reasonable ph- macokinetic parameters, and good safety profiles. Therefore, research tools must be available in drug discovery to rapidly screen for compounds with favorable drug-like properties, and thus adequate resources can be directed to projects with high potential. Optimization in Drug Discovery: In Vitro Methods is a compilation of detailed experimental protocols necessary for setting up a variety of assays important in compound evaluation. A total of 25 chapters, contributed by many experts in their research areas, cover a wide spectrum of subjects including physicochemical properties, abso- tion, plasma binding, metabolism, drug interactions, and toxicity. A good pharmacokinetic profile has long been recognized as an imp- tant drug-like characteristic. Pharmacokinetic parameters are affected by many properties of drug molecules such as physicochemical nature, abso- tion, metabolic stability, and so on.

This detailed volume addresses key issues and subtle nuances involved in developing hydrophilic matrix tablets as an approach to oral controlled release. It brings together information from more than five decades of research and development on hydrophilic matrix tablets and provides perspective on contemporary issues. Twelve comprehensive chapters explore a variety of topics including polymers (hypromellose, natural polysaccharides and polyethylene oxide) and their utilization in hydrophilic matrices, critical interactions impacting tablet performance, in vitro physical and imaging techniques, and microenvironmental pH control and mixed polymer approaches, among others. In one collective volume, Hydrophilic Matrix Tablets for Oral Controlled Release provides a single source of current knowledge, including sections of previously unpublished data. It is an important resource for industrial and academic scientists investigating and developing these oral controlled release formulations.

In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue. The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations, a knowledgeof science, a graspof compliance, and an appreciation of common practices. Sinceearly2000, Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums. As a book lover, I also have a good collection of technical books. Unfor- nately, most of the stability related volumes are outdated. Many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththepharmac- tical industryto accommodatethese changes;however, thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice. Therefore, I hoped to ass- ble a practical handbook to ?ll this v

The series Structure and Bonding publishes critical reviews on topics of research concerned with chemical structure and bonding. The scope of the series spans the entire Periodic Table and addresses structure and bonding issues associated with all of the elements. It also focuses attention on new and developing areas of modern structural and theoretical chemistry such as nanostructures, molecular electronics, designed molecular solids, surfaces, metal clusters and supramolecular structures. Physical and spectroscopic techniques used to determine, examine and model structures fall within the purview of Structure and Bonding to the extent that the focus is on the scientific results obtained and not on specialist information concerning the techniques themselves. Issues associated with the development of bonding models and generalizations that illuminate the reactivity pathways and rates of chemical processes are also relevant.
The individual volumes in the series are thematic. The goal of each volume is to give the reader, whether at a university or in industry, a comprehensive overview of an area where new insights are emerging that are of interest to a larger scientific audience. Thus each review within the volume critically surveys one aspect of that topic and places it within the context of the volume as a whole. The most significant developments of the last 5 to 10 years should be presented using selected examples to illustrate the principles discussed. A description of the physical basis of the experimental techniques that have been used to provide the primary data may also be appropriate, if it has not been covered in detail elsewhere. The coverage need not be exhaustive in data, but should rather be conceptual, concentrating on the new principles being developed that will allow the reader, who is not a specialist in the area covered, to understand the data presented. Discussion of possible future research directions in the area is welcomed. Review articles for the individual volumes are invited by the volume editors.
Readership: research scientists at universities or in industry, graduate students
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For all customers who have a standing order to the print version of Structure and Bonding, we offer free access to the electronic volumes of the Series published in the current year via SpringerLink.

The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals select the most appropriate medication to effectively treat children and ensure minimal side effects.

This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.

This book presents a detailed overview of the development of new viral vector-based vaccines before discussing two major applications: preventive vaccines for infectious diseases and therapeutic cancer vaccines. Viral vector-based vaccines hold a great potential for development into successful pharmaceutical products and several examples at the advanced pre-clinical or clinical stage are presented. Nevertheless, the most efforts were focused on novel and very innovative technologies for new generation of vector-based vaccines. Furthermore, specific topics such as delivery and adjuvant and protection strategies for cell-mediated-based vaccines are presented. Given its scope, the book is a "must read" for all those involved in vaccine development, both in academia and industrial vaccine development.

In developing countries, access to affordable medicines for the treatment of diseases such as AIDS and malaria remains a matter of life or death. In Africa, for instance, more than one million children die each year from malaria alone, a figure which could soon be far higher with the extension of patent rules for pharmaceuticals. Previously, access to essential medicines was made possible by the supply of much cheaper generics, manufactured largely by India; from 2005, however, the availability of these drugs is threatened as new WTO rules take effect. Halting the spread of malaria and HIV/AIDS is one of the eight Millennium Goals adopted at the UN Millennium Summit, which makes this a timely and topical book. Informed analysis is provided by internationally renowned contributors who look at the post-2005 world and discuss how action may be taken to ensure that intellectual property regimes are interpreted and implemented in a manner supportive to the right to protect public health and, in particular, to promote access to medicines for all.

Finding current, detailed information on the analysis of drug-related compounds is challenging at best. While almost everyone engaged in the study of these compounds has accumulated a vast variety of data over time, a single-source, comprehensive review of that data would be an invaluable resource to have. Instrumental Data for Drug Analysis (IDDA), Third Edition is that resource, presenting the latest information on these compounds in a thorough, straightforward format. What's new in the Third Edition: Presents FT-Raman Spectra tables Includes information and analysis relating to 125 new drugs, including Zoloft, Claritin, Ambien, and the latest generation of narcotics Organizes information on each drug in a simple, streamlined format

This book focuses on the different compounds (polyphenols, sterols, alkaloids terpenes) that arise from the secondary metabolism of plants and fungi and their importance for research and industry. These compounds have been the backbone and inspiration of various industries like the food, pharmaceutical and others to produce synthetic counterparts. Furthermore, many of these compounds are still widely used to carry out specific functions in all these industries. This book offers a compilation of different texts from world leading scientists in the areas of chemistry, biochemistry, plant science, biotechnology which compile information on each group of secondary metabolism compounds, and their most important applications in the food, pharmaceutical, cosmetic and textile industry. By showcasing the best uses of these compounds, the chemistry behind their production in plants and fungi, this book is a valuable resource and a "go to" artifact for various audiences. The new approach this book offers, by linking research and the application of these compounds, makes it interesting as an inspiration for new research or as a hallmark of what has been done in the secondary metabolism of plants and fungi in recent years. Although this book may be technical, it is also enjoyable as an integral reading experience due to a structured and integrated flow, from the origins of secondary metabolism in organisms, to the discovery of their effects, their high intensity research in recent years and translation into various industries. Beyond learning more on their chemistry, synthesis, metabolic pathway, readers will understand their importance to different research and industry.

This book describes how microbes can be used as effective and sustainable resources to meet the current challenge of finding suitable and economical solutions for biopharmaceuticals, enzymes, food additives, nutraceuticals, value added biochemicals and microbial fuels, and discusses various aspects of microbial regulatory activity and its applications. It particularly focuses on the design, layout and other relevant issues in industrial microbe applications. Moreover, it discusses the entire microbial-product supply chain, from manufacturing sites to end users, both in domestic and international markets, providing insights into the global marketing of microbes and microbial biomass-derived products. Further, it includes topics concerning the effective production and utilization of eco-friendly biotechnology industries. It offers a valuable, ready-to-use guide for technologists and policymakers developing new biotechnologies.

This book gives an overview of therapeutic drug monitoring (TDM) and its clinical application. It also highlights recent advances in toxicological studies, as they relate to therapeutic drug monitoring. This is one of the few books available on the market that covers TDM. Therapeutic drug monitoring (TDM) is a clinical decision-making tool that enables dosage regimen adjustments based on clinical and laboratory measurements. TDM not only involves the measuring of drug concentrations but also interpretation of the results. There is a strong correlation between drug concentrations in body fluids and outcome than between dose and outcome. The chapters include coverage of analytical techniques, pharmacokinetics, therapeutic indices, artificial intelligence and recent advances in toxicological studies. The book fills a gap in published literature and provides reliable information on; Analytical techniques in TDM and clinical toxicology TDM and pharmacokinetic studies TDM of drugs with narrow therapeutic indices Artificial intelligence in TDM and clinical toxicology Future directions and challenges

In the next couple of years the human genome will be fully sequenced. This will provide us with the sequence and overall function of all human genes as well as the complete genome for many micro-organisms. Subsequently it is hoped, by means of powerful bioinformatic tools, to determine the gene variants that contribute to various multifactorial diseases and genes that exist in certain infectious agents but not humans. As a consequence, this will allow us to define the most appropriate levels for drug intervention. It can be expected that the number of potential drug targets will increase, possibly by a factor of 10 or more. Nevertheless, sequencing the human genome or, for that matter, the genome of other species will only be the starting point for the understanding of their biological function. Structural genomics is a likely follow-up, combined with new techniques to validate the therapeutic relevance of such newly discovered targets. Accordingly, it can be expected that in the near future we will witness a substantial increase in novel putative targets for drugs. To address these new targets effectively, we require new approaches and innovative tools. At present, two alternative, yet complementary, techniques are employed: experimental high-throughput screening (HTS) of large compound libraries, increasingly provided by combinatorial chemistry, and computational methods for virtual screening and de novo design. As kind of status report on the maturity of virtual screening as a technique in drug design, the first workshop on new approaches in drug design and discovery was held in March 1999, at Schloss Rauischholzhausen, near Marburg in Germany. More than 80 scientists gathered and discussed their experience with the different techniques. The speakers were invited to summarize their contributions together with their impressions on the present applicability of their approach. Several of the speakers followed this request which is summarized in this publication."

Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.

A significant improvement in the safety of modern vaccines has been the development of subunit vaccines, as these are composed of very well-defined and highly pure components, often recombinant proteins. However, since protein-based antigens in general are weakly immunogenic by themselves, co-administration of adjuvants is required to induce potent and persistent specific immune responses. In recent years, there has been substantial progress in the discovery of new efficient adjuvants for subunit vaccines that are often classified into delivery systems and immunopotentiating compounds that constitute pathogen-associated molecular patterns, such as the toll-like receptor ligands. The combination of delivery systems and immunopotentiators has appeared to represent extraordinarily good adjuvants due to concomitant enhanced antigen delivery and potent stimulation of innate immunity. Many of these adjuvants are of a particulate nature and mimic the structure and/or composition of microbes in a reductionist fashion. Examples are liposomes, polymeric nanoparticles, emulsions and virus-like particles. However, there are a substantial number of pharmaceutical challenges associated with the subunit vaccine development process due to the complex nature of the antigen-adjuvant combinations. These challenges will be presented and discussed in this book. The objective of the book is to compile the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. The books goal is to provide a comprehensive overview of the scientific and regulatory challenges facing scientists who research and develop subunit vaccines. The scope of the book is wide. It is written in a manner that will enlighten newcomers to the field (e.g., PhD students or experienced scientist switching fields) yet provide an in-depth knowledge that would benefit a skilled worker in the field. "

This book is intended for a broad readership, in particular, those working or interested in drug discovery coming from various disciplines such as medicinal chemistry, pharmacology, drug metabolism and pharmacokinetics, bioanalysis, clinical sciences, biochemistry, pharmaceutics, and toxicology. It provides, for the first time, a completely integrated look at multiple aspects of ADME sciences (absorption, distribution, metabolism, and excretion) in a summary format that is clear, concise, and self-explanatory. DMPK in Drug Discovery - Guide to Data Interpretation and integration leverages the prior knowledge from the first book that covers the basics of each concept (Drug Metabolism and Pharmacokinetics Quick Guide). This reference book is meant to be used day to day and provides many useful tables (used for data interpretation), figures, and case studies that can facilitate drug discovery. The case studies are intended to be short and relevant to the topic discussed and present another dimension to the discussions.

Interest in chemical entities capable of blocking or modifying cell metabolism ultimately goes back to the discovery of the structure of DNA in the 1950s. Understanding of the biochemical processes involved in cell metabolism rapidly led to the idea that compounds could be designed which might interfere with these processes, and thus could be used in the treatment of the diseases caused by viral infection. Since then, several classes of drugs have been discovered which depend for their effect on modification of the proper functioning of nucleic acids and, with the introduction of acyclovir for the treatment of Herpes infections, nucleoside analogues have become the cornerstone of antiviral chemotherapy. The success of the early nucleoside agents, the toxicity and metabolic instability of many nucleoside analogues, and the effects of viral pathogens on public health are driving the design, synthesis and evaluation of new nucleoside analogues, with much attention turning to nucleosides containing non natural' sugar analogues. This book focuses on the development of these agents, and draws together all the available material in an easily consulted form, which at the same time guides the reader into the research literature on the subject. Written primarily for the medicinal chemist, coverage includes both synthetic strategies and outline guidance on the main trends in biological activity. Particular attention is drawn to the comparison of synthetic routes to compounds with their natural analogues. Finally, the important antiviral activities of the compounds are treated, including anti-retrovirus, anti-hepadnavirus and anti-herpes virus properties. Written mainly for medicinal chemists inthe pharmaceutical industry and synthetic organic chemists in academe, this book will also be attractive to researchers in institutions focusing on cellular metabolism. Advanced students of organic chemistry will find the clear discussion of the synthetic strategies adopted in the development of these compounds a useful introduction to this exciting and challenging area.

Nearly three thousand papers and patents are dedicated to the actual or potential uses of cyclodextrins in pharmacy and pharmaceutical formulations. This is the first book written for pharmacists and pharmaceutical technologists which not only critically summarizes the enormous amount of literature available, but which can be used as a handbook when looking for solutions to practical problems. The fundamentals -- chemistry of cyclodextrins and their derivatives -- their physical and chemical properties are condensed to the most relevant items in Chapters 1 and 2. Chapter 3 deals with the adsorption, metabolism and toxicological properties of cyclodextrins. Chapter 4 explains the formulation, structure, composition and advantageous effects of the cyclodextrin inclusion complexes. Chapter 5 describes the methods for preparation and characterization of drug/cyclodextrin complexes. Chapters 6 and 7 are dedicated to the pharmacokinetics, biopharmaceutical and technological aspects of drug/CD complexes. Chapter 8 treats the application and effects of cyclodextrins in various drug formulations. The Appendix comprises a collection of recipes for any type of drug formulation. This book is aimed at those who use cyclodextrins in drug formulations, to improve the properties of existing drug formulations, or who want to prepare quite new formulations.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

The marine environment has been, and continues to be, a fruitful source of novel chemical compounds that are not found in terrestrial and freshwater organisms. Many of these substances show potential biomedical applications, which could lead to development of new pharmaceutical products. Research on the utilization of natural products from marine organisms is growing by leaps and bounds; one important reason why being that, investigators, through new diving technologies, are becoming able to explore at greater depths. Studies of these marine natural products include investigations of neuronal membrane-active toxins, ion channel blockers, antitumor and antiviral agents, and anti-inflammatory molecules. This volume is the sixth in the ongoing series.

This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs.

Specific topics covered in this book include: Solution, suspension, gel, nanoparticle, microparticle, and implant dosage formsRefillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets

"Drug Product Development for the Back of the Eye" is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets

"Drug Product Development for the Back of the Eye" is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets

"Drug Product Development for the Back of the Eye" is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. "

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Progress in Drug Research is a prestigious book series (founded in 1959) which provides extensive expert-written reviews on a wide spectrum of highly topical areas in current pharmaceutical and pharmalogical research. Each volume contains fully cross-referencing indexes which link the volumes together, forming a virtually encyclopaedic work. The series thus serves as an important, time-saving source of information for researchers concerned with drug research and all those who need to keep abreast of the many recent developments in the quest for new and better medicines.

Volume 50 in the series includes:

P.N. Kaul: Drug discovery: Past, present and future

M. Rohmer: Isoprenoid biosynthesis via the mevalonate -- independent route, a novel target for antibacterial drugs

G. Edwards and A.H. Weston: Endothelium, -derived hyperpolarizing factor -- a critical appraisal

R.W. Rockhold: Glutamatic involvement in psychomotor stimulant action

J.M. Colacino and K.A. Staschke: The identification and development of antiviral agents for the treatment of chronic hepatitis B virus infection

T.D. Johnson: Polyamines and cerebral ischemia