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.

Pharmaceutical Calculations: A Conceptual Approach, is a book that combines conceptual and procedural understanding for students and will guide you to master prerequisite skills to carry out accurate compounding and dosage regimen calculations. It is a book that makes the connection between basic sciences and pharmacy. It describes the most important concepts in pharmaceutical sciences thoroughly, accurately and consistently through various commentaries and activities to make you a scientific thinker, and to help you succeed in college and licensure exams. Calculation of the error associated with a dose measurement can only be carried out after understanding the concept of accuracy versus precision in a measurement. Similarly, full appreciation of drug absorption and distribution to tissues can only come about after understanding the process of transmembrane passive diffusion. Early understanding of these concepts will allow reinforcement and deeper comprehension of other related concepts taught in other courses. More weight is placed on the qualitative understanding of fundamental concepts, like tonicity vs osmotic pressure, diffusion vs osmosis, crystalloids vs colloids, osmotic diuretics vs plasma expanders, rate of change vs rate constants, drug accumulation vs drug fluctuation, loading dose vs maintenance dose, body surface area (BSA) vs body weight (BW) as methods to adjust dosages, and much more, before considering other quantitative problems. In one more significant innovation, the origin and physical significance of all final forms of critical equations is always described in detail, thus, allowing recognition of the real application and limitations of an equation. Specific strategies are explained step-by-step in more than 100 practice examples taken from the fields of compounding pharmacy, pharmaceutics, pharmacokinetics, pharmacology and medicine.

Stockley's Herbal Medicines Interactions is now in its second edition and remains a unique collaboration between a team of experts in the fields of drug interactions, clinical herbal medicines, phytopharmacovigilance and regulation of herbal medicinal products. It provides an invaluable reference text for all healthcare professionals who require evidence-based information on the interactions of conventional medicines with herbal medicines, dietary supplements and nutraceuticals. Stockley's Herbal Medicines Interactions brings together available data on over 180 of the most commonly used herbal medicines, dietary supplements and nutraceuticals in highly structured, rigorously researched, and fully referenced monographs. Extensively updated for this second edition over 40 new monographs have been added for herbal medicines and dietary supplements, including Blue cohosh, Bergamot, Carnitine derivatives, Goat's rue, Hibiscus, Holy basil, Juniper, Kava and Squill. Substantial updates have been undertaken to the standing content, including revisions of the interactions of St John's wort, Milk thistle, Evening primrose oil, Ginkgo and many others. Key features include: Ease of use - structured format allows user to target key information at-a-glance. Clinically relevant - each monograph contains a concise summary on the available evidence and guidance on how the interaction can be managed. Ratings system - simple and intuitively understood, familiar to users of key drug interactions reference works. Worldwide appeal - as well as commonly used synonyms nomenclature includes approved pharmacopoeial names from Europe and the US. Indexing - full, comprehensive interactions indexing, with lead-ins from appropriate synonyms.

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.

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 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.

This new volume focuses on clinical biochemistry fundamentals, cell culture techniques, and drug discovery and development concepts. It deals with three different fields of clinical research: cell culture, clinical biochemistry, and drug discovery and development. The book introduces cell animal and bacterial culture techniques and their potential uses as well as cell culture techniques. The biochemistry aspect of the book covers the principles of clinical biochemistry and biochemical analysis, biochemical aids to clinical diagnosis, measurement, and quality control. The book also presents important concepts in cell membrane receptor signal transduction pathways as drug targets. The drug development focus of the book discusses the fundamentals of human disease and drug discovery. Various in silico, in vitro, and in vivo approaches for drug discovery are examined, along with a discussion on drug delivery carriers and clinical trials. Overall, the volume provides an overview of the journey from clinical fundamentals to clinical output.

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.

Provides the first accessible introduction to concepts and strategies employed in clinical trials of drugs. Also covers essential strategies and proctical insights on clinical research methodology.

This volume of Pharmaceutical Biocatalysis starts with a discussion on the importance of biocatalytic synthesis approaches for a sustainable and environmentally friendly production of pharmaceuticals and active pharmaceutical ingredients. Among the enzymes discussed in detail with respect to their pharmaceutical relevance are cyclic nucleotide phosphodiesterases playing an important role in modulating signal transduction in various cell types; human DOPA decarboxylase, related to Parkinson's disease and aromatic amino acid decarboxylase deficiency; and phospholipase D enzymes as drug targets. Isocitrate dehydrogenase 1 and 2 mutations are novel therapeutic targets in acute myeloid leukemia. An additional chapter is devoted to the use of enzymes for prodrug activation in cancer therapy. The other topics include small-molecule inhibitors targeting receptor tyrosine kinases in cancer, -Lactams and related compounds as antibacterials, non-vitamin K oral anticoagulants for the treatment of thromboembolic diseases, and the molecular mechanisms for statin pleiotropy and its clinical relevance in cardiovascular diseases. The last chapter is a review of lysosomal storage disorders with an overview of approved drugs for treating these disorders by enzyme replacement therapy.

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.

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.

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.

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.

50th Anniversary Edition of the groundbreaking case-based pharmacotherapy text, now a convenient two-volume set. Celebrating 50 years of excellence, Applied Therapeutics, 12th Edition, features contributions from more than 200 experienced clinicians. This acclaimed case-based approach promotes mastery and application of the fundamentals of drug therapeutics, guiding users from General Principles to specific disease coverage with accompanying problem-solving techniques that help users devise effective evidence-based drug treatment plans. Now in full color, the 12th Edition has been thoroughly updated throughout to reflect the ever-changing spectrum of drug knowledge and therapeutic approaches. New chapters ensure contemporary relevance and up-to-date IPE case studies train users to think like clinicians and confidently prepare for practice. NEW! Chapters on Developmental Disorders (including Autism) and Prostate Cancer empower students with expert insight on these increasingly critical areas of therapy. NEW! Full-color design keeps students engaged and clarifies complex content. UPDATED! More than 800 case studies challenge students to integrate and apply therapeutic principles in the context of specific clinical situations, cultivating the critical thinking skills essential to optimal patient outcomes. Core Principles listed at the beginning of each chapter encourage students to explore critical concepts and enrich their understanding and evidence-based decision-making capabilities.

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.

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

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 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.

Primarily intended for physicians and health care professionals who are treating obese patients, this book explores current and future options for drug treatment of obesity puts them into perspective against available alternative treatments. Distinguished scientists and clinical investigators provide reviews of each individual topic, covering a wide range of subjects from pathophysiology of obesity to the benefits of weight loss. The core sections on pharmacotherapy deal with currently available drugs and drugs in pre-clinical development, complemented with sections on non-drug treatment and general therapeutic aspects to provide an integrated view of therapeutic approaches to the treatment of obesity and its associated syndromes.

Increase in antibiotic resistance has forced researchers to develop new drugs against microorganisms. Lipopeptides are produced as secondary metabolites by some microorganisms. Computer-aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates provides the identification of novel ligands for different antimicrobial lipopeptides. Along with identification, it also provides some of the in silico drug design processes, namely homology modelling, molecular docking, QSAR studies, drug ADMET studies and pharmacophore studies to check the ligand-lipopeptide interaction. Some lipopeptides have shown anti-cancerous properties too, and this book discusses the required templates to design new drugs using computational techniques. Key Features: Focuses on the use lipopeptides as new antimicrobial compounds Presents the basics of in silico modelling for design and development of new drug molecules, and is therefore of interest to beginners in the field Provides a step-by-step process for identification of drug molecules and testing its efficacy in silico Couples with courses on patents and intellectual property rights

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.