Chronic pain places a tremendous burden on both the patient and the healthcare system. The use of opioids to address pain has resulted in negative impacts. As practitioners work to undo the current opioid crisis, options to manage pain need a new approach. Advanced Therapeutics in Pain Medicine offers pioneering approaches to this intransigent problem providing a functional medicine approach toward treating pain. This book is dedicated to the advancement of non-opioid therapeutic options that offer real progress in reaching a future of better pain management. With an emphasis on pathophysiology, chapters review various types of pain and propose comprehensive treatment plans. These include manual therapies, novel pharmacologic and plant-based approaches, hormonal effects on pain pathways, as well as psychological and lifestyle interventions. Features * Written by a multi-discplinary team, the book provides clinicians with multiple non-opioid treatment considerations. * Enables practitioners to shift from a "one size fits all' treatment approach toward individualized patient care. * Includes case studies to help educate the provider on how to implement treatment plans in practice. Written by a team of physicians, pharmacists, psychologists and researchers, this important book offers a much needed step forward in optimizing pain care and benefits practitioners who care for patients experiencing chronic pain.

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."-Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book's practical, detailed approach draws on the authors' 30 years' experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What's New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

Chronic pain places a tremendous burden on both the patient and the healthcare system. The use of opioids to address pain has resulted in negative impacts. As practitioners work to undo the current opioid crisis, options to manage pain need a new approach. Advanced Therapeutics in Pain Medicine offers pioneering approaches to this intransigent problem providing a functional medicine approach toward treating pain. This book is dedicated to the advancement of non-opioid therapeutic options that offer real progress in reaching a future of better pain management. With an emphasis on pathophysiology, chapters review various types of pain and propose comprehensive treatment plans. These include manual therapies, novel pharmacologic and plant-based approaches, hormonal effects on pain pathways, as well as psychological and lifestyle interventions. Features * Written by a multi-discplinary team, the book provides clinicians with multiple non-opioid treatment considerations. * Enables practitioners to shift from a "one size fits all' treatment approach toward individualized patient care. * Includes case studies to help educate the provider on how to implement treatment plans in practice. Written by a team of physicians, pharmacists, psychologists and researchers, this important book offers a much needed step forward in optimizing pain care and benefits practitioners who care for patients experiencing chronic pain.

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

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product.

Providing integrated solutions, this book discusses:

• The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology
• The physicochemical characteristics and stability of peptides and proteins
• The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids
• The opportunities and challenges of non-parenteral delivery of peptides and proteins
• Risk factors, specifically the development of an unwanted immune response
• A simulation approach to describe the fate of peptides and proteins upon administration to a biological system
• The documentation required to register a protein-based drug

Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Sleep Deprivation, Stimulant Medications, and Cognition provides a review, synthesis and analysis of the scientific literature concerning stimulant medications and neurobehavioral performance, with an emphasis on critically evaluating the practical utility of these agents for maintaining cognitive performance and alertness in sleep-deprived (but otherwise healthy) individuals. The book explores the nature of sleep loss-induced cognitive deficits, neurophysiologic basis of these deficits, relative efficacy and limitations of various interventions (including non-pharmacological), and implications for applying these interventions in operational environments (commercial and military). Readers of this volume will gain a working knowledge of: * Mechanisms contributing to sleep loss-induced cognitive deficits * Differential effects of stimulant compounds on various aspects of cognition * Considerations (such as abuse liability) when applying stimulant interventions in operational settings * Current state and future directions for including stimulants in comprehensive fatigue-management strategies. This text is key reading for researchers and trainees in sleep and psychopharmacology.

Discussing existing techniques, ongoing research, new approaches, and basic concepts in the treatment of nail diseases, Topical Nail Products and Ungual Drug Delivery summarizes the current knowledge and represents a jumping-off point for creating novel techniques of drug delivery across the nail. A growing area of pharmaceutical research, the search for efficient delivery techniques that can cross the nail barrier has yielded several effective strategies, brought together in this book. Topics Include Nail anatomy, physiology, diseases, and treatment Permeability of the nail plate Topical nail formulations Approaches to enhance ungual and trans-ungual drug delivery In vitro and in vivo models to evaluate topical nail formulations Nail sampling techniques Bioengineering of the nail Trans-ungual iontophoresis Pharmacokinetics of drugs in the nail apparatus Onychopharmacokinetics: proposed model insight Photodynamic therapy of nail diseases The nail as a surrogate for investigating drug use

This forward-looking book focuses on the recent advances in nanomedicine and drug delivery. It outlines the extraordinary new tools that have become available in nanomedicine and presents an integrated set of perspectives that describe where we are now and where we should be headed to put nanomedicine devices into applications as quickly as possible, while also considering the possible dangers of nanomedicine. The book considers the full range of nanomedicinal applications that employ molecular nanotechnology inside the human body, from the perspective of a future practitioner in an era of widely available nanomedicine. Written by some of the most innnovative minds in medicine and engineering, this unique volume will help professionals understand cutting-edge and futuristic areas of research that can have tremendous payoff in terms of improving human health. Readers will find insightful discussions of nanostructured intelligent materials and devices that are considered technically feasible and which have a high potential to produce advances in medicine in the near future. Topics include: Health benefits of phytochemicals and the application of colloidal delivery systems Study of non-covalent attachment of recombinant targeting proteins to polymer-modified Adenoviral gene delivery vectors The role of nanoparticles as adjuvants for mucosal vaccine delivery Poly(amido-amine)s as delivery styems for biologically active substances Antimicrobial activity of silver nanoparticles Nanomedicine in the use of cancer treatment Dendrimers, capsules based on lipid vesicles for drug delivery Many other recent achievements

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies-experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections-causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

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.

This innovative study charts the beginnings, history and fate of Interferon - one of modern medicine's most famous and infamous drugs. Interferon is part of the medical profession's armoury against viral infection, cancer and MS. The story of its development and use is one of survival in the face of remarkable cycles of promise and disappointment as a miracle drug. By telling this story, Toine Pieters' book provides insight into the research, manufacture, and marketing of new bio-molecules that mark modern medical science. Pieters' closely argued book adopts a multi-disciplinary approach in seeking to trace the extraordinary voyage of interferon. Through the lens of interferon's voyage, the book explores the interaction of the broad range of actors driving medical science: *biological and clinical researchers *the pharmaceutical industry *high-powered government agencies *doctors and patients *the media. The book demonstrates how research on interferon led to new clinical definitions of cancer and a new rationale for therapeutic use of the drug. Interferon provides a marvellous insight into the development of one of the most controversial drugs of our time. It enhances our understanding of how medicine manufacture and marketing all played a part in pushing back the boundaries of research, from the post-penicillin era to the genetics revolution in medicine. This study is of particular interest to undergraduates and postgraduates in the fields of History of Medicine, Pharmacology, Medical Genetics and History of Science.

Guides You on the Development and Implementation of B-R Evaluations Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B-R assessments in medicine development and regulation, the need for both a common B-R framework and patient input into B-R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA's Center for Devices and Radiological Health. The third section examines key elements of B-R evaluations in a product's life cycle, such as uncertainty evaluation and quantification, quantifying patient B-R trade-off preferences, ways to identify subgroups with the best B-R profiles, and data sources used to assist B-R assessment. The fourth section equips practitioners with tools to conduct B-R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B-R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B-R evaluations.

DHEA and the Brain reviews a range of existing studies regarding DHEA administration to animals and humans. Chapter authors evaluate DHEA metabolism in tissues and organs, explore DHEA effects in the liver that may be of importance to the brain, and discuss recent findings regarding how DHEA is made in the brain. New perspectives about the neuroprotective effects of DHEA are presented, as well as insight related to DHEA metabolism in the brain. A number of health benefits have been associated with dehydroepiandrosterone (DHEA), including anti-cancer, anti-osteoporosis, anti-atherosclerosis, anti-diabetes, immuno-stimulating, and memory-enhancing effects. This has prompted millions of people to take this hormone as a daily nutritional supplement. However, there is some concern that prolonged self-administration may result in future health problems, as well as unease about potential side effects due to the production of steroid derivatives in the tissues. Featuring an esteemed panel of contributors, this volume provides an authoritative overview of the research concerning DHEA and the brain. It presents a variety of innovative approaches and ideas for future investigations into the physiological actions of this hormone.

Herbs and Healers from the Ancient Mediterranean through the Medieval West brings together eleven papers by leading scholars in ancient and medieval medicine and pharmacy. Fittingly, the volume honors Professor John M. Riddle, one of today's most respected medieval historians, whose career has been devoted to decoding the complexities of early medicine and pharmacy. "Herbs" in the title generally connotes drugs in ancient and medieval times; the essays here discuss interesting aspects of the challenges scholars face as they translate and interpret texts in several older languages. Some of the healers in the volume are named, such as Philotas of Amphissa, Gariopontus, and Constantine the African; many are anonymous and known only from their treatises on drugs and/or medicine. The volume's scope demonstrates the breadth of current research being undertaken in the field, examining both practical medical arts and medical theory from the ancient world into early modern times. It also includes a paper about a cutting-edge Internet-based system for ongoing academic collaboration. The essays in this volume reveal insightful research approaches and highlight new discoveries that will be of interest to the international academic community of classicists, medievalists, and early-modernists because of the scarcity of publications objectively evaluating long-lived traditions that have their origin in the world of the ancient Mediterranean.

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery, Sixth Edition features the latest research surrounding the application of pharmacology in drug discovery in an effort to equip readers with a deeper understanding of complex and rapid changes in this field. Written by well-respected pharmacologist, Terry P. Kenakin, this primer is an indispensable resource for anyone involved in drug discovery. This edition has been reorganized for better flow and clarity and includes material on new technologies for screening (virtual, DNA encoded libraires, fragment-based) and a major section on phenotypic (target agnostic) screening for new leads and determination of drug targets. With full color illustrations as well as new examples throughout, this book remains a top reference for all industry and academic scientists and students directly involved in drug discovery or pharmacologic research. New material includes a discussion of the determination of target engagement, including numerous new ways to demonstrate the physical interaction of molecules with drug targets and new drug candidates such a mRNA, gene therapy, antibodies and information on CRISPR and genomics.

Design of new processes that avoid the use of toxic reagents has been the focus of intense research of late. Catalysis by metals and non-metals offers diverse opportunities for the development of new organic reactions with promising range of selectivities-chemoselectivity, regioselectivity, diastereoselectivity, and enantioselectivity. Furthermore, these transformations frequently occur under mild conditions, tolerate a broad array of functional groups, and proceed with high stereoselectivity. The area of catalysis is sometimes referred to as a 'foundational pillar' of green chemistry. Catalytic reactions often reduce energy requirements and decrease separations because of increased selectivity; they are also capable of permitting the use of renewable feedstocks of less toxic reagents or minimizing the quantities of reagents needed. New catalytic organic synthesis methodologies have, thus, offered several possibilities for considerable improvement in the eco-compatibility of fine chemical production. Hence, these catalytic methodologies have emerged as powerful tools for the efficient and chemoselective synthesis of heterocyclic molecules. Key Features: Presents the synthesis of different five-membered heterocycles. Contains the most up-to-date information in this fast-moving field. Covers novel catalytic approaches used in the study and application of catalysts in synthetic organic reactions. Presents new methodologies for the synthesis of heterocycles.

Although numerous studies have been made of the Western educated political elite of colonial Nigeria in particular, and of Africa in general, very few have approached the study from a perspective that analyzes the impacts of indigenous institutions on the lives, values, and ideas of these individuals. This book is about the diachronic impact of indigenous and Western agencies in the upbringing, socialization, and careers of the colonial Igbo political elite of southeastern Nigeria. The thesis argues that the new elite manifests the continuity of traditions and culture and therefore their leadership values and the impact they brought on African society cannot be fully understood without looking closely at their lived experiences in those indigenous institutions where African life coheres. The key has been to explore this question at the level of biography, set in the context of a carefully reconstructed social history of the particular local communities surrounding the elite figures. It starts from an understanding of their family and village life, and moves forward striving to balance the familiar account of these individuals in public life, with an account of the ongoing influences from family, kinship, age grades, marriage and gender roles, secret societies, the church, local leaders and others. The result is not only a model of a new approach to African elite history, but also an argument about how to understand these emergent leaders and their peers as individuals who shared with their fellow Africans a dynamic and complex set of values that evolved over the six decades of colonialism.

The advancement of the life sciences and the technosciences has enhanced the longevity of citizens in the Western world, and half of the generation born in the first decade of the new millennium is now expected to live to the age of one hundred years. In a society with such longevity and affluence, consumption of health-related goods and services such as pharmaceuticals and scanning procedures may be seen as a sustainable source of income for the industries that promote it. Though the healthcare sector has traditionally been organized in the public sector in Europe and in the private sector in the US, the recent advancement of new therapies and direct-to-consumer marketing have opened up new streams of consumption and revenue for health care goods and services around the globe. This book examines the so-called 'bioeconomy' as a new economic and commercial field that emphasizes the management of individual life, including the regulation and control of weight and food consumption and other issues pertaining to individual well-being. In addition, the bioeconomy includes a variety of practices based on commercial interests such as organ donations, reproductive medicine and technologies, and what has been referred to as the tissue economy - the various forms of trade with human tissues. Author Alexander Styhre provides a thorough introduction to the bioeconomy, exploring this new and unique intersection of the life sciences and the technosciences with more traditional consumer markets.

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
  

Since most therapeutic efforts have been predominantly focused on pharmaceuticals that target proteins, there is an unmet need to develop drugs that intercept cellular pathways that critically involve nucleic acids. Progress in the discovery of nucleic acid binding drugs naturally relies on the availability of analytical methods that assess the efficacy and nature of interactions between nucleic acids and their putative ligands. This progress can benefit tremendously from new methods that probe nucleic acid/ligand interactions both rapidly and quantitatively. A variety of novel methods for these studies have emerged in recent years, and Methods for Studying DNA/Drug Interactions highlights new and non-conventional methods for exploring nucleic acid/ligand interactions. Designed to present drug-developing companies with a survey of possible future techniques, the book compares their drawbacks and advantages with respect to commonly used tools. Perhaps more importantly, this book was written to inspire young scientists to continue to advance these methods into fruition, especially in light of current capabilities for assay miniaturization and enhanced sensitivity using microfluidics and nanomaterials.

Because enzyme-catalyzed reactions exhibit higher enantioselectivity, regioselectivity, substrate specificity, and stability, they require mild conditions to react while prompting higher reaction efficiency and product yields. Biocatalysis in the Pharmaceutical and Biotechnology Industries examines the use of catalysts to produce fine chemicals and chiral intermediates in a variety of pharmaceutical, agrochemical, and other biotechnological applications. Written by internationally recognized scientists in biocatalysis, the authors analyze the synthesis of chiral intermediates for over 60 brand-name pharmaceuticals for a wide range of drug therapies and treatments. From starting material to product, the chapters offer detailed mechanisms that show chiral intermediates and other by-products for each reaction-including hydrolytic, acylation, halogenation, esterification, dehalogenation, oxidation-reduction, oxygenation, hydroxylation, deamination, transamination, and C-C, C-N, C-O bonds formation. Cutting-edge topics include advanced methodologies for gene shuffling and directed evolution of biocatalysts; the custom engineering of enzymes; the use of microbial cells and isolated biocatalysts; the use of renewable starting materials; and generating novel molecules by combinatorial biocatalysis and high-throughput screening. Focusing on industrial applications, the book also considers factors such as bulk processes, instrumentation, solvent selection, and techniques for catalyst immobilization, reusability, and yield optimization throughout. Biocatalysis in the Pharmaceutical and Biotechnology Industries showcases the practical advantages and methodologies for using biocatalysts to develop and produce chiral pharmaceuticals and fine chemicals.

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.