Oral Bioavailability Assessment

Understand and assess the design, delivery, and efficacy of orally administered drugs A practical guide to understanding oral bioavailability, one of the major hurdles in drug development and delivery, Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications is designed to help chemists, biologists, life science researchers, pharmaceutical scientists, pharmacologists, clinicians, and graduate and students become familiar with the fundamentals and practices of the science of oral bioavailability. The difference in rate and extent between a drug taken orally and the actual amount of a drug reaching the circulatory system, oral bioavailability is an essential parameter for determining the efficacy and adverse effects of new and developing medications, as well as finding an optimal dosing regimen. This book provides a much-needed one-stop resource to help readers better understand and appreciate the many facets and complex problems of oral bioavailability, including the basic barriers to oral bioavailability, the methods used to determine relevant parameters, and the challenges of drug delivery. In addition, this comprehensive book discusses biological and physicochemical methods for improving bioavailability, integrates physicochemistry with physiology and molecular biology, and includes several state-of-the-art technologies and approaches—Caco-2 cell culture model, MDCK, and other related cell culture models—which are used to study the science of oral bioavailability.

The peroral application (swallowing) of a medicine means that the body must first resorb the active substance before it can begin to take effect. The efficacy of drug uptake depends on the one hand on the chemical characteristics of the active substance, above all on its solubility and membrane permeability. On the other hand, it is determined by the organism's ability to absorb pharmaceuticals by way of specific transport proteins or to excrete them. Since many pharmacologically active substances are poorly suited for oral intake, a decisive criterion for the efficacy of a medicine is its so-called bioavailability. Written by an international team from academia and the pharmaceutical industry, this book covers all aspects of the oral bioavailability of medicines. The focus is placed on methods for determining the parameters relevant to bioavailability. These range from modern physicochemical techniques via biological studies in vitro and in vivo right up to computer-aided predictions. The authors specifically address possibilities for optimizing bioavailability during the early screening stage for the active substance. Its clear structure and comprehensive coverage make this book equally suitable for researchers and lecturers in industry and teaching.

The gold standard for industrial research now completely revised in line with current trends in the field, with all contributions extensively updated or rewritten. In 21 chapters readers can benefit from the key working knowledge of today's leading pharmaceutical companies, including Pfizer, AstraZeneca, and Roche. Drug developers from industry and academia present all the factors governing drug bioavailability, complete with practical examples and real-life data. Part I focuses on in vitro and in vivo measurements of physicochemical properties, such as membrane permeability and ionization. Part II discusses solubility and gastrointestinal absorption, while the third part is devoted to metabolism and excretory mechanisms. The much revised and expanded part IV surveys current in silico approaches to predict drug properties needed to estimate the bioavailability of any new drug candidate. The final part shows how poor bioavailability may be improved by various approaches during the development process. No other publication offers the same level of treatment on this crucial topic in modern drug development.

This book covers all aspects of bioavailability, as related to environmental contaminants. After a discussion of the definition of bioavailability and its context, focus is placed on the role of risk assessment and bioavailability. Methods of analysis are then discussed including a range of atomic spectroscopic and electrochemical techniques for metal analysis and chromatographic approaches for persistent organic pollutants (POPs). The occurrence, properties and eco-toxicity of POPs and metals in the soil/sediment environment are discussed. Particular emphasis is placed on the uptake of POPs and metals by plants (phytoextraction). Examples of POPs and metals in the environment are reviewed. Methods to assess the bioavailability of POPs and metals in the environment are discussed. The particular approaches considered are: non-exhaustive extraction techniques single extraction techniques sequential extraction techniques use of cyclodextrin and surfactants in-vitro gastrointestinal methods including physiological-based extraction test the use of bioasssays including earthworms. Finally, selected case studies highlight the importance of determining the bioavailability of POPs and metals.

Offers solutions and best practices to respond to recurrent problems and contemporary challenges in the field Since the publication of the first edition of Environmental Impact Assessment in 2003, both the practice and theory of impact assessment have changed substantially. Not only has the field been subject to a great deal of new regulations and guidelines, it has also evolved tremendously, with a greater emphasis on strategic environmental, sustainability, and human health impact assessments. Moreover, there is a greater call for impact assessments from a global perspective. This Second Edition, now titled Impact Assessment to reflect its broader scope and the breadth of these many changes, offers students and practitioners a current guide to today's impact assessment practice. Impact Assessment begins with an introduction and then a chapter reviewing conventional approaches to the field. Next, the book is organized around recurrent problems and contemporary challenges in impact assessment process design and management, enabling readers to quickly find the material they need to solve tough problems, including: How to make impact assessments more influential, rigorous, rational, substantive, practical, democratic, collaborative, ethical, and adaptive How each problem and challenge-reducing process would operate at the regulatory and applied levels How each problem can be approached for different impact assessment types—sustainability assessment, strategic environmental assessment, project-level EIA, social impact assessment, ecological impact assessment, and health impact assessment How to link and combine impact assessment processes to operate in situations with multiple overlapping problems, challenges, and impact assessment types How to connect and combine impact assessment processes Each chapter first addresses the topic with current theory and then demonstrates how that theory is applied, presenting requirements, guidelines, and best practices. Summaries at the end of each chapter provide a handy tool for structuring the design and evaluation of impact assessment processes and documents. Readers will find analyses and new case studies that address such issues as multi-jurisdictional impact assessment, climate change, cumulative effects assessment, follow-up, capacity building, interpreting significance, and the siting of major industrial and waste facilities. Reflecting current theory and standards of practice, Impact Assessment is appropriate for both students and practitioners in the field, enabling them to confidently respond to a myriad of new challenges in the field.

Risk Assessment Explore the fundamentals of risk assessment with references to the latest standards, methodologies, and approaches The Second Edition of Risk Assessment: A Practical Guide to Assessing Operational Risks delivers a practical exploration of a wide array of risk assessment tools in the contexts of preliminary hazard analysis, job safety analysis, task analysis, job risk assessment, personnel protective equipment hazard assessment, failure mode and effect analysis, and more. The distinguished authors discuss the latest standards, theories, and methodologies covering the fundamentals of risk assessments, as well as their practical applications for safety, health, and environmental professionals with risk assessment responsibilities. “What If”/Checklist Analysis Methods are included for additional guidance. Now in full color, the book includes interactive exercises, links, videos, and online risk assessment tools that can be immediately applied by working practitioners. The authors have also included: Material that reflects the latest updates to ISO standards, the ASSP Technical Report, and the ANSI Z590.3 Prevention through Design standard New hazard phrases for chemical hazards in the Globally Harmonized System, as well as NIOSH’s new occupational exposure banding tool The new risk-based approach featured in the NAVY IH Field Manual New chapters covering business continuity, causal factors analysis, and layers of protection analysis and barrier analysis An indispensable resource for employed safety professionals in a variety of industries, business leaders and staff personnel with safety responsibilities, and environmental engineers Risk Assessment: A Practical Guide to Assessing Operational Risks is also useful for students in safety, health, and environmental science courses.

Introduces risk assessment with key theories, proven methods, and state-of-the-art applications Risk Assessment: Theory, Methods, and Applications  remains one of the few textbooks to address current risk analysis and risk assessment with an emphasis on the possibility of sudden, major accidents across various areas of practice—from machinery and manufacturing processes to nuclear power plants and transportation systems. Updated to align with ISO 31000 and other amended standards, this all-new  2nd Edition  discusses the main ideas and techniques for assessing risk today. The book begins with an introduction of risk analysis, assessment, and management, and includes a new section on the history of risk analysis. It covers hazards and threats, how to measure and evaluate risk, and risk management. It also adds new sections on risk governance and risk-informed decision making; combining accident theories and criteria for evaluating data sources; and subjective probabilities. The risk assessment process is covered, as are how to establish context; planning and preparing; and identification, analysis, and evaluation of risk.  Risk Assessment  also offers new coverage of safe job analysis and semi-quantitative methods, and it discusses barrier management and HRA methods for offshore application. Finally, it looks at dynamic risk analysis, security and life-cycle use of risk.  Serves as a practical and modern guide to the current applications of risk analysis and assessment, supports key standards, and supplements legislation related to risk analysis Updated and revised to align with ISO 31000 Risk Management and other new standards and includes new chapters on security, dynamic risk analysis, as well as life-cycle use of risk analysis Provides in-depth coverage on hazard identification, methodologically outlining the steps for use of checklists, conducting preliminary hazard analysis, and job safety analysis Presents new coverage on the history of risk analysis, criteria for evaluating data sources, risk-informed decision making, subjective probabilities, semi-quantitative methods, and barrier management Contains more applications and examples, new and revised problems throughout, and detailed appendices that outline key terms and acronyms Supplemented with a book companion website containing Solutions to problems, presentation material and an Instructor Manual Risk Assessment: Theory, Methods, and Applications, Second Edition  is ideal for courses on risk analysis/risk assessment and systems engineering at the upper-undergraduate and graduate levels. It is also an excellent reference and resource for engineers, researchers, consultants, and practitioners who carry out risk assessment techniques in their everyday work.

The latest edition of this perennial bestseller instructs and updates students and clinicians on the basic principles of psychological assessment and measurement, recent changes in assessment procedures, and the most widely used tests in counseling practice today. Dr. Danica Hays guides counselors in the appropriate selection, interpretation, and communication of assessment results. This edition covers more than 100 assessment instruments used to evaluate substance abuse and other mental health disorders, intelligence, academic aptitude and achievement, career and life planning, personal interests and values, assessment of personality, and interpersonal relationships. In addition, a new chapter on future trends in assessment discusses the changing cultural landscape, globalization, and technology. Perfect for introductory classes, this text provides students and instructors with practical tools such as bolded key terminology; chapter pretests, summaries, and review questions; self-development and reflection activities; class and field activities; diverse client case examples; practitioner perspectives illustrating assessment in action; and resources for further reading. PowerPoint slides, a test bank, a sample syllabus, and chapter outlines to facilitate teaching are available to instructors by request to ACA.

A new guide to conducting more comprehensive and meaningful psychological assessments of young children Early Childhood Assessment presents a thorough, step-by-step approach to the comprehensive psychological assessment of young children. In addition to covering major psychological tests, this invaluable resource includes specific guidelines and formats for interviewing parents and other caregivers, observing children and caregiver-child interaction, conducting dynamic assessments, writing reports, and evaluating outcomes of recommended interventions. Dr. Lidz's approach encourages a broad range of observation with an overarching objective of completing a picture of the «whole» child, from family life to social-emotional and neuropsychological functioning. She leads the reader through each step of a comprehensive assessment, touching on the major data sources necessary for a full understanding of the child within different environments. Throughout the book, Dr. Lidz advocates best assessment practices that reflect the interests of children and families. Features useful information on: * Conducting initial interviews and observations for setting the course of the assessment * Using standardized and nonstandardized approaches to generate both qualitative and quantitative data * Viewing children and families within their cultural contexts * Integrating assessment data sources to generate meaningful recommendations and readable reports Plus: * Includes unique chapters on play, observation of parent-child and teacher-child interactions, and dynamic assessment Early Childhood Assessment is a valuable tool for professionals and students who are concerned about the richness and complexity of children's development within their families and communities.