This book brings together a collection of empirical case studies featuring a wide spectrum of medical innovation. While there is no unique pathway to successful medical innovation, recurring and distinctive features can be observed across different areas of clinical practice. This book examines why medical practice develops so unevenly across and within areas of disease, and how this relates to the underlying conditions of innovation across areas of practice. The contributions contained in this volume adopt a dynamic perspective on medical innovation based on the notion that scientific understanding, technology and clinical practice co-evolve along the co-ordinated search for solutions to medical problems. The chapters follow an historical approach to emphasise that the advancement of medical know-how is a contested, nuanced process, and that it involves a variety of knowledge bases whose evolutionary paths are rooted in the contexts in which they emerge. This book will be of interest to researchers and practitioners concerned with medical innovation, management studies and the economics of innovation. Chapter 5 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9781138860346_oachapter5.pdf

Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity. The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods. A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

This book walks you step-by-step through the whole research process so you can get up to speed understanding and doing your own research. In their friendly, down to earth style, the authors lay the theoretical foundations you need to consume and critique research, before showing how to translate this into action when tackling your own literature review or research project. This second edition: Draws on a wealth of examples from midwifery, four fields of nursing including mental health nursing and child nursing, and a range of health care specialities. Covers new and updated NMC professional education standards and maps all relevant policy and law. Supports your learning with reflective exercises, online activities and quizzes that enable you to be confident in your understanding and develop your thinking. Whether you're encountering research and evidence-based practice for the first time or refreshing your methods knowledge, this is the ideal research companion for nurses and midwives pre-registration, post-registration and beyond.

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.

In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biostatisticians have begun to use a randomized phase II trial that compares an experimental therapy with a prospective control therapy. Randomized Phase II Cancer Clinical Trials explains how to properly select and accurately use diverse statistical methods for designing and analyzing phase II trials. The author first reviews the statistical methods for single-arm phase II trials since some methodologies for randomized phase II trials stem from single-arm phase II trials and many phase II cancer clinical trials still use single-arm designs. The book then presents methods for randomized phase II trials and describes statistical methods for both single-arm and randomized phase II trials. Although the text focuses on phase II cancer clinical trials, the statistical methods covered can also be used (with minor modifications) in phase II trials for other diseases and in phase III cancer clinical trials. Suitable for cancer clinicians and biostatisticians, this book shows how randomized phase II trials with a prospective control resolve the shortcomings of traditional single-arm phase II trials. It provides readers with numerous statistical design and analysis methods for randomized phase II trials in oncology.

As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

This book examines developments in qualitative psychotherapeutic research. It focuses on different methods and aspects of clinical practice. These range from the experiences of service users and clinicians, examining in detail different aspects of how therapy gets done in practice, to critiquing the politics and ideologies of psychotherapy practice. It aims to reflect the diversity that characterises this developing field and to represent practice-based research carried out in different clinical settings, from different perspectives and in different sociocultural contexts. The wide range of research projects presented arise from a network of clinicians and psychotherapy researchers who have established an international transdisciplinary forum for dedicated qualitative research on a range of topics in the field of mental health, using a variety of methodologies and theoretical approaches. In the spirit of dialogue, this book further provides chapters written by key practitioners in the field of qualitative research in mental health discussing these contributions. This book was originally published as a special issue of the European Journal of Psychotherapy & Counselling.

Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at:* Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials* Health professionals who wish to conduct their own trials, or participate in other people's studies* People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Lead by both children's rights perspectives and methodological arguments there is an increasing emphasis on children and young people's participation in health and social care research by researchers, policy makers and funding bodies - with many now considering the active involvement of children and young people a requirement. However, although increasingly important, there is little exploration of how to address and overcome the many challenges arising from their participation. Divided into five parts, this practical book begins by considering what research with young people is and why we should do it, before leading the reader into how to undertake it. The book then provides practical examples of action and finishes with reflections about the whole process. Bringing together a variety of experienced researchers, from a wide range of backgrounds in health and social care and including young people, the chapters provide insight for practical action, as well as critical and theoretical reflection. Involving Children and Young People in Health and Social Care Research includes issues on: Understanding the reasons and processes for involving children and young people in research Making sure that involvement is meaningful and not merely tokenistic Developing research methods that are commensurate with different ages and abilities Ensuring adequate training and preparation, for children, young people and adults to make involvement meaningful Power and relationships between young people researchers and adult researchers Sustaining young people's interest and motivation Addressing ethical issues that arise throughout the research journey Committed to partnership and participation throughout the entire process of the active involvement of children and young people in health and social care research, this text provides invaluable insights and is a resource for all those conducting research in and with children and young people.

A highly practical guide to public health intervention development. This book has been developed to assist anyone involved with effective health promotion project design. It cuts through the complex theories and technical frameworks to provide a 6 step formula for creating effective and sustainable interventions. Key features Adopts a pragmatic approach that addresses barriers and challenges to project delivery Utilises the Six Steps in Quality Intervention Development framework - a unique model designed specifically to improve intervention planning Combines the theory and concepts behind intervention development with practical methods of delivery on the ground Includes detailed case studies that provide examples of how the six steps can be used for successful intervention design As the health needs of an increasingly globalised world continue to evolve and shift, effective planning and intervention work will only become more important. Written by leading researchers and experts who draw on a wealth of experience in the field, this book will be essential reading for any student, practitioner or policy maker requiring an understanding of practical intervention design.

The study of human reproduction has focused on reproductive 'success' and on the struggle to achieve this, rather than on the much more common experience of 'failure', or reproductive loss. Drawing on the latest research from The UK and Europe, The United States, Australia and Africa, this volume examines the experience of reproductive loss in its widest sense to include termination of pregnancy, miscarriage, stillbirth, perinatal and infant death, as well as - more broadly - the loss of desired normative experiences such as that associated with infertility, assisted reproduction and the medicalisation of 'high risk' pregnancy and birth. Exploring the commonalities, as well as issues of difference and diversity, Understanding Reproductive Loss presents international work from a variety of multi-disciplinary perspectives and will appeal to sociologists, anthropologists and other social scientists with interests in medicine, health, the body, death studies and gender.

Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.The book, with its example-oriented approach that includes numerous SAS and R code fragments, is an essential resource for statisticians and graduate students specializing in medical research. The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.

Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling, fitting models with exposure and response driven by complex dynamics, and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis, causal inference to eliminate confounding biases, and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology, clinical pharmacology, epidemiology, and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented, this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition, students can see how complicated methodology and models are applied to practical situations.

An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment's efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies. Statistical Methods in Drug Combination Studies fills that gap, covering all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this comprehensive reference: Describes statistical models used to characterize dose-response patterns of monotherapies and evaluate the combination drug synergy Offers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interaction Introduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate use Examines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviews Evaluates computational tools and software packages used to apply novel statistical methods in combination drug development Statistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.

The leading figure in qualitative health research (QHR), Janice M. Morse, asserts that QHR is its own separate discipline--distinct from both traditional health research and other kinds of qualitative research--and examines the implications of this position for theory, research, and practice. She contends that the health care environments transform many of the traditional norms of qualitative research and shape a new and different kind of research tradition. Similarly, the humanizing ethos of qualitative health research has much to teach traditional researchers and practitioners in health disciplines. She explores how the discipline of QHR can play out in practice, both in the clinic and in the classroom, in North America and around the world. A challenging, thought-provoking call to rethink how to conduct qualitative research in health settings.

Led by both children s rights perspectives and methodological arguments, there is an increasing emphasis on children and young people s participation in health and social care research by researchers, policy makers and funding bodies with many now considering the active involvement of children and young people a requirement. There is little exploration of how to address and overcome the many challenges arising from their participation, however.

Divided into five parts, this practical book begins by considering what research with young people is and why we should do it, before leading the reader into how to undertake it. The book then provides practical examples of action and finishes with reflections about the whole process. Bringing together a variety of experienced researchers, from a wide range of backgrounds in health and social care and including young people, the chapters provide insight for practical action, as well as critical and theoretical reflection. Involving Children and Young People in Health and Social Care Research includes issues on:

• Understanding the reasons and processes for involving children and young people in research
• Making sure that involvement is meaningful and not merely tokenistic
• Developing research methods that are commensurate with different ages and abilities
• Ensuring adequate training and preparation, for children, young people and adults to make involvement meaningful
• Power and relationships between young people researchers and adult researchers
• Sustaining young people s interest and motivation
• Addressing ethical issues that arise throughout the research journey

Committed to partnership and participation throughout the entire process of the active involvement of children and young people in health and social care research, this text provides invaluable insights and is a resource for all those conducting research in and with children and young people.

One of the first studies of an exciting new development in global biotechnology, this cutting edge text examines the extent of the transnational movements of tissues, stem cells, and expertise, in the developing governance framework of India.

Documenting the impact of local and global governance frames on the everyday conduct of research, this groundbreaking book traces the journey of spare human embryos in IVF clinics to public and private laboratories engaged in isolating stem cells for potential therapeutic application. The discussion also examines the gender dimension as a potential site for exploitation in the sourcing of embryonic and other biogenic materials, and suggests that a moral economy has developed in which the ethical values of the global 'North' support and encourage the donation of abundant and ethically neutral embryos by the 'South'.

This unique exploration is grounded in an empirical, multi-sited ethnographic study that takes a thoroughly comparative analysis of the ethical, religious and social issues in Europe, the United States, and organ donations already prevalent in India. In this theoretically-sensitive analysis, the authors use the resources of social anthropology and the social sciences in an innovative text which will appeal to postgraduates and professionals in the areas of STS studies, genetics, bioethics, and anthropology.

This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental industrial and clinical perspective reflecting the many advances in techniques and methodology. The title will cover new material including the use of enzymes for the synthesis and resolution of enantiomeric compounds as well, as their use in drug discovery; how stereochemistry impacts on decisions taken during the ADMET (absorption, distribution, metabolism, excretion, toxicity) stage of drug discovery; issues faced during the final stages of the drug development process; the impact of ICH (International Conference on Harmonisation) on the use of single isomer drugs; racemic switches; and legal perspectives looking at IP and patent issues surrounding chiral switches and marketing single enantiomer switches.

This Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.

New topics include:

• The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery
• How stereochemistry impacts decisions made in the Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) stages of drug discovery
• A chapter on pharmacokinetics and pharmacodynamics that discusses the issues faced during the final stages of the drug development process
• The impact of International Conference on Harmonisation on the use of single isomer drugs
• Chiral switches
• The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs
• A chapter on the legal perspectives of patent issues surrounding chiral switches and the marketing of single enantiomer switches
• This will be a one-stop shop for pharmaceutical scientists and chemists working with chiral drug molecules