Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Increasingly, pharmaceuticals are available as the solutions to a wide range of human health problems and health risks, minor and major. This book portrays how pharmaceutical use is, at once, a solution to, and a difficulty for, everyday life. Exploring lived experiences of people at different stages of the life course and from different countries around the world, this collection highlights the benefits as well as the challenges of using medicines on an everyday basis. It raises questions about the expectations associated with the use of medications, the uncertainty about a condition or about the duration of a medicine regimen for it, the need to negotiate the stigma associated with a condition or a type of medicine, the need to access and pay for medicines and the need to schedule medicine use appropriately, and the need to manage medicines' effects and side effects. The chapters include original empirical research, literature review and theoretical analysis, and convey the sociological and phenomenological complexity of 'living pharmaceutical lives'. This book is of interest to all those studying and researching social pharmacy and the sociology of health and illness.

The rich biodiversity of Borneo provides many useful plants for medicinal purposes. Written by experts in the field, Medicinal Plants of Borneo provides a guide and introduction to the medicinal plants from Borneo used traditionally as well as plants whose medicinal uses have been recently discovered. These include anti-HIV plants - such as Calophyllum lanigerum (calanolide A) - and anti-cancer plants - such as Aglaia foveolata (silvestrol). The book also provides information on the relevant medicinal chemistry, such as isolated bioactive compounds and the mechanism of action, where available. FEATURES Discusses the rich experience in the use of medicinal plants and the wide diversity of Borneo's botanical resources Presents plants with medicinal properties from a scientific perspective Provides readers with current information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers a range of chemical, botanical and pharmacological diversities Forms an important part of the Natural Products Chemistry of Global Plants series due to an increasing global interest in natural products and botanical drugs Simon Gibbons is Head of the School of Pharmacy, University of East Anglia, UK, and a Professor of Natural Product Chemistry. He was formerly a Professor of Medicinal Phytochemistry at the School of Pharmacy, University College London (UCL). Stephen P. Teo is a forest botanist with the Forest Department, Sarawak, Malaysia.

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

The rich biodiversity of Borneo provides many useful plants for medicinal purposes. Written by experts in the field, Medicinal Plants of Borneo provides a guide and introduction to the medicinal plants from Borneo used traditionally as well as plants whose medicinal uses have been recently discovered. These include anti-HIV plants - such as Calophyllum lanigerum (calanolide A) - and anti-cancer plants - such as Aglaia foveolata (silvestrol). The book also provides information on the relevant medicinal chemistry, such as isolated bioactive compounds and the mechanism of action, where available. FEATURES Discusses the rich experience in the use of medicinal plants and the wide diversity of Borneo's botanical resources Presents plants with medicinal properties from a scientific perspective Provides readers with current information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers a range of chemical, botanical and pharmacological diversities Forms an important part of the Natural Products Chemistry of Global Plants series due to an increasing global interest in natural products and botanical drugs Simon Gibbons is Head of the School of Pharmacy, University of East Anglia, UK, and a Professor of Natural Product Chemistry. He was formerly a Professor of Medicinal Phytochemistry at the School of Pharmacy, University College London (UCL). Stephen P. Teo is a forest botanist with the Forest Department, Sarawak, Malaysia.

Increasingly, pharmaceuticals are available as the solutions to a wide range of human health problems and health risks, minor and major. This book portrays how pharmaceutical use is, at once, a solution to, and a difficulty for, everyday life. Exploring lived experiences of people at different stages of the life course and from different countries around the world, this collection highlights the benefits as well as the challenges of using medicines on an everyday basis. It raises questions about the expectations associated with the use of medications, the uncertainty about a condition or about the duration of a medicine regimen for it, the need to negotiate the stigma associated with a condition or a type of medicine, the need to access and pay for medicines and the need to schedule medicine use appropriately, and the need to manage medicines' effects and side effects. The chapters include original empirical research, literature review and theoretical analysis, and convey the sociological and phenomenological complexity of 'living pharmaceutical lives'. This book is of interest to all those studying and researching social pharmacy and the sociology of health and illness.

View the Table of Contents. Read the Introduction.

aThese challenging essays mark the transformation of medication from a tradition of need assessed by physicians, to a culture that far exceeds a basic threshold for drugs on demand on the part of the public.a
--"Choice"

"Nowhere do pharmaceutical companies sell more drugs, make more money, affect more lives, or wield more power than in the United States. These sophisticated but accessible essays trace the history of eight types of prescription blockbusters, from antibiotics to Viagra, and show how they have changed Americans' thinking about disease, consumer rights, and normality itself. They force us to confront the paradox of a pill-taking society that wages war on some drugs but avidly seeks out others to economically profitable if not always therapeutically benign effect."
--David Courtwright, author of "Forces of Habit" and "Dark Paradise"

aA set of fascinating case studies. . . . Anyone who has taken prescription medications can benefit by reading it.a--"Metapsychology Online Reviews"

With Americans paying more than $200 billion each year for prescription pills, the pharmaceutical business is the most profitable in the nation. The popularity of prescription drugs in recent decades has remade the doctor/patient relationship, instituting prescription-writing and pill-taking as an integral part of medical practice and everyday life.

Medicating Modern America examines the meanings behind this pharmaceutical revolution through the interconnected histories of eight of the most influential and important drugs: antibiotics, mood stabilizers, hormone replacement therapy, oral contraceptives, tranquilizers, stimulants, statins, and Viagra. All of these drugs have been popular, profitable, influential, and controversial, and the authors take a historical approach to studying their development, prescription, and consumption. This perspective locates the histories of prescription medicines in specific cultural contexts while revealing the extent to which contemporary debates about pharmaceutical drugs echo concerns voiced by Americans in the past.

Exploring the rich and multi-faceted history of pharmaceutical drugs in the United States, Medicating Modern America unveils the untold stories behind America's pharmaceutical obsession.

Contributors include: Robert Bud, Jennifer R. Fishman, Jeremy A. Greene, David Healy, Suzanne White Junod, Ilina Singh, Andrea Tone, and Elizabeth Siegel Watkins.

Over the past five years, the immense financial pressure on the development and manufacturing of biopharmaceuticals has resulted in the increasing use and acce- ance of disposables, which are discarded after harvest and therefore intended only for single use. In fact, such disposables are implemented in all the main bioprocess production stages today and an even higher growth than those in the biopharmac- tical market is predicted (reaching double figures). Alongside disposable filter capsules, membrane chromatography units, tubing, connectors, flexible containers processing or containing fluids, freezer systems, mixers and pumps, and fully c- trolled disposable bioreactors of up to 2,000 L culture volume are already available on the market. Numerous studies highlight the advantages of disposable bioreactors and reveal their potential for simple, safe and fast seed inoculum production, process devel- ment and small as well as middle volume production (e.g. bioactive substances, viruses for vaccines and gene therapies etc.). They suggest that such disposable bioreactors (typically characterized by the cultivation chamber or bag from plastic materials) may be advantageous for plant, animal and microbial cells. Running industrial activities such as CFD-modelling, development of single-use process monitoring and control technology, and standardized film formulations are attempting to resolve the limitations of the current disposable bioreactors. These achievements, along with substantial improvements in product yield, will reduce the use of stainless steel in the biomanufacturing facilities of the future.

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings's College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Biomedical Application of Nanoparticles explores nanoparticles, their chemical and physicals properties, and how they interact in biological systems with proteins, immune system and targeted cells. Risk assessment of nanoparticles for human is described, including: cellular paradigms, transcriptomics and toxicogenomics. Finally, the applications of nanoparticles in medicine and antioxidant regenerative therapeutics are presented in several chapters with emphasis on how nanoparticles enhance transport of drugs across biological membrane barriers and therefore may enhance drug bioavailability.

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.

In the fast-developing field of nanomedicine, a broad variety of materials have been used for the development of advanced delivery systems for drugs, genes, and diagnostic agents. With the recent breakthroughs in the field, we are witnessing a new age of disease management, which is governed by precise regulation of dosage and delivery. This book presents the advances in the use of lipid-based and inorganic nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. The materials discussed include liposome-scaffold systems, elastic liposomes, targeted liposomes, solid lipid nanoparticles, lipoproteins, exosomes, porous inorganic nanomaterials, silica nanoparticles, and inorganic nanohybrids. The book provides all available information about them and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully.

Building on its best-selling predecessors, Basic Statistics and Pharmaceutical Statistical Applications, Third Edition covers statistical topics most relevant to those in the pharmaceutical industry and pharmacy practice. It focuses on the fundamentals required to understand descriptive and inferential statistics for problem solving. Incorporating new material in virtually every chapter, this third edition now provides information on software applications to assist with evaluating data. New to the Third Edition Use of Excel (R) and Minitab (R) for performing statistical analysis Discussions of nonprobability sampling procedures, determining if data is normally distributed, evaluation of covariances, and testing for precision equivalence Expanded sections on regression analysis, chi square tests, tests for trends with ordinal data, and tests related to survival statistics Additional nonparametric procedures, including the one-sided sign test, Wilcoxon signed-ranks test, and Mood's median test With the help of flow charts and tables, the author dispels some of the anxiety associated with using basic statistical tests in the pharmacy profession and helps readers correctly interpret their results using statistical software. Through the text's worked-out examples, readers better understand how the mathematics works, the logic behind many of the equations, and the tests' outcomes.

The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. At the same time, the industry is also criticized for its marketing and pricing practices and for its apparent anticompetitive responses to generic competition. Even its research and development priorities are criticized as being too closely driven by the goal of maximizing shareholder value, rather than the health of the public. Unfortunately, many of the critics of the industry fail to understand the complexities of the industry and its role in the nations healthcare system. This book uses the tools of economic analysis to explore the conflicting priorities and aims of the pharmaceutical industry, from both an American and worldwide perspective.
This is the second edition of a uniquely comprehensive and balanced discussion of pharmaceutical policy issues. All the chapters of the former edition have been fully re-written and extensively updated.
In addition, the book includes six new chapters on emerging topics such as the broadened role of FDA regulations and the increasing diversity of the industry. An entire chapter is devoted to the biotechnology industry and one to alternative medicines, often called "nutraceuticals." Another new chapter discusses segments of the industry that specialize in particular activities including generic drugs and drug delivery systems. The recent controversial expansion of Medicare to cover outpatient drugs is discussed in depth. The introduction is also updated to address the volatile pace of pharmaceutical innovation and how the pharmaceuticalindustry has responded to the emergence of managed care.

This book focuses on thielocin B1 (TB1), which was found to be an inhibitor of protein-protein interactions (PPIs) of proteasome assembling chaperone (PAC) 3 homodimer, and elucidates the mechanism by nuclear magnetic resonance (NMR) studies. Interfaces of PPIs recently have been expected to be novel therapeutic targets, while it is difficult to apply conventional methodology based on lock and key theory. The author achieved the first total synthesis of TB1 and its spin-labeled derivative to carry out NMR experiments because the supply of TB1 from natural sources was limited. Unique 2,2',6,6'-tetrasubstituted diphenyl ether moiety of TB1 was synthesized from a depsidone skeleton by chemoselective reduction of lactone. In the process of elongating side wings, efficient formylation utilizing dichloromethyl methyl ether-silver trifluoromethanesulfonate was developed for the sterically hindered aromatic compound. NMR titration experiments and paramagnetic relaxation enhancement observation of PAC3 homodimer were performed with synthesized TB1 and its molecular probe, respectively. The results of the above NMR studies and additional in silico docking studies suggested that TB1 promotes the dissociation to monomeric PAC3 after interaction with PAC3 homodimer. The rare mechanism shown in this book indicates a potential novel drug target in the interfaces of PPIs with no cavity or groove.

The book concentrates on powder flow properties, their measurement and applications. These topics are explained starting from the interactions between individual particles up to the design of silos. A wide range of problems are discussed - such as flow obstructions, segregation, and vibrations. The goal is to provide a deeper understanding of the powder flow, and to show practical solutions.

Integrating advances in molecular biology into bioprocesses presents a continuous challenge to scientists and bioengineers. This series is conceived to help meet this challenge. It examines and assesses the feasibility of new approaches for the modification of cellular function such as gene expression, protein processing, secretion, glycosylation, immortalisation, proliferation, and apoptosis as well as the systematic study of the metabolic genotype-phenotype relationship. The series provides detailed coverage of the methodology for improving cellular properties of cells used in the production of biopharmaceuticals, gene and cell therapies and tissue engineering. It also seeks to explain the cellular mechanisms underlying in vitro physiological activity and productivity. This volume, which is based on presentations at the European Workshop on Animal Cell Engineering' held in Costa Brava, Spain, contains a collection of chapters relating to cellular function and modification by leading authorities in several different areas of basic research and the biopharmaceutical industry.

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

As pharmaceutical companies look to develop single enantiomers as drug candidates, chemists are increasingly faced with the problems associated with this subclass of organic synthesis. "The Handbook of Chiral Chemicals, Second Edition" highlights the problems associated with the production of chiral compounds on a commercial scale. The handbook first elaborates upon starting materials obtained from a 'chiral pool', which can be derived from natural products. Then it explains methods and reactions that can introduce or influence stereogenic centers, particularly asymmetric hydrogenations, oxidations, pericyclic reactions, and enzymatic methods.While hydrogenations have been the most widely employed approach for the large-scale synthesis of several commercial compounds, the search for the ideal catalyst has consistently led researchers to enzymes present in biological systems. Several chapters concentrate on understanding how to manipulate enzymes for catalyzing new reactions for taking new substrates. Other significant topics include chiral auxiliaries, chromatographic techniques, enantiomers-specific reactions, and resolution. This second edition updates all its chapters, illustrating the speed of development in this field, and features new chapters that highlight successful approaches in an industrial setting. "The Handbook of Chiral Chemicals, Second Edition" is a guide to advances in the field that result in more efficient and cost-effective synthesis of chiral chemicals.

This volume is comprised of papers presented at the Third International Conference on Pharmacoepidemiology, held September 9-11, 1987, in Minneapolis, Minnesota. The book is divided into four sections, which reflect the four themes of the conference: Social Impact of Pharmacoepidemiology; Drug Epidemiology and the Law; Drug Surveillance; and Drugs, Populations, and Outcomes: Specific Studies. The collection of papers discusses the social and legal impact of epidemiology, the system of checks and balances that is necessary for the field, the importance of core support for researchers, and the goal of an enlightened and informed public, including the media, consumer advocates, and the courts. Contributing authors offer perspectives from academia, practice, government, industry and the law. Numerous tables and figures are included to illustrate many of the papers within the text. This book offers substantial reading for epidemiologists and individuals interested in the field of pharmacoepidemiology.

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.