For the convenience of research workers, particularly those with limited knowledge of embryology, we have put together a series of tables to enable rapid identification of specific stages of embryonic development in the more commonly used mammals. Because if its frequent usage the chick embryo is included this atlas.

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

If you are working in a time-sensitive context, need to deliver research findings so they can be used to inform decisions, or are finding it difficult to access research funding for long-term qualitative research, this book will help you. Introducing 'rapid qualitative research', it demonstrates how you can conduct high quality qualitative research within time, access and resource constraints. The book uses real world examples to illustrate the benefits and challenges of using rapid qualitative research designs. Focusing on the when, why and how, it explains the difference between cutting corners and making quick, well-informed research choices that support rigorous, credible research. Key features of the book include discussion questions and exercises for you to reflect on and apply your learning, as well as two case study chapters of real-world research so you can see rapid research in action. Written by the world's leading expert on this subject, this book contains the theoretical and practical nuts and bolts you need to reframe existing qualitative methods, speed up your research, and make tangible contributions to your field. It is the perfect companion for any researcher, final-year undergraduate or postgraduate student looking to conduct rapid, but rigorous, qualitative research.

Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.

Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

With the advent of sophisticated general programming environments like Mathematica, the task of developing new models of metabolism and visualizing their responses has become accessible to students of biochemistry and the life sciences in general. Modelling Metabolism with Mathematica presents the approaches, methods, tools, and algorithms for modelling the chemical-dynamics of metabolic pathways. The authors explain the concepts underpinning the deterministic theory of chemical and enzyme kinetics, present a graded series of computer models of metabolic pathways leading up to that of the human erythrocyte, and document a consistent set of rate equations and associated kinetic parameters.

The experimental and theoretical study of metabolism in mammalian cells has a long and fruitful history, but our understanding of cellular metabolism at the molecular level is far from complete. This book enables its readers to formulate their own models of time-dependent metabolic systems and aids them in the quest for the many fundamental and clinically relevant discoveries that remain to be made.

Autoradiography is the localization within a solid specimen of a radiolabel by placing the specimen against a layer of detector material. Many types of specimen can be studied, from whole organisms to ultra-this cryosections. Indeed, rather than being a single technique, autoradiography is a collection of methods with certain features in common. Between them, these techniques can supply information at the macroscopic, microscopic, and ultrastructural levels, and their use is important to biological scientists in a variety of research areas. In this handbook, the author provides a comprehensive overview of the major techniques of autoradiography. With the aid of numerous illustrations, the various methods are clearly described, and the information which they can provide is discussed. Suggestions for further reading are provided at the end of most chapters. The student involved in biological or biomedical research will find this an invaluable introduction to the theory and techniques of autoradiography, and a clear guide to choosing the correct approach for his or her particular application. It will also be of interest to more experienced researchers, who are already familiar with one particular method, and wish to broaden their approach to another level.

Contents:
Introduction 1. Health and the Net - an Overview 2. Getting Online 3. The World Wide Web 4. Finding Health Information on the Internet 5. Communicating with Other Health Professionals by E-Mail 6. Joining Health Discussion Groups, Mailing Lists Etc. 7. The Gateway to Free Health and Medical Resources 8. Publishing on the World Wide Web 9. Online Help with your Health Studies and Job Search Questions and Answers Appendices Worksheets

Correctly understanding and using medical statistics is a key skill for all medical students and health professionals. In an informal and friendly style, Medical Statistics from Scratch provides a practical foundation for everyone whose first interest is probably not medical statistics. Keeping the level of mathematics to a minimum, it clearly illustrates statistical concepts and practice with numerous real-world examples and cases drawn from current medical literature. Medical Statistics from Scratch is an ideal learning partner for all medical students and health professionals needing an accessible introduction, or a friendly refresher, to the fundamentals of medical statistics.

A volume in the Principles and Applications in Engineering series, Clinical Engineering focuses on managing the deployment of medical technology and integrating it appropriately with desired clinical practices. It provides a description of the wide range of responsibilities clinical engineers encounter, describes technology management and assessment in detail, and reviews the standards and regulatory agencies of interest. Then the book details various biomedical sensors, considering both biologic and electronic factors in sensor performance. Finally, the book covers bioinstrumentation, addressing traditional topics and recently developed instruments and devices such as pulse oximeters and home-care monitoring devices.

Phage Display in Biotechnology and Drug Discovery, Second Edition provides a comprehensive view of the impact and promise of phage display in drug discovery and biotechnology. Building on the success of its previous edition, the book discusses current theories, principles, and methods in the field and demonstrates applications for peptide phage display, protein phage display, and the development of novel antibodies. The book provides readers with an overview of the amazing breadth of the impact that phage display technology has had on the study of proteins in general as well as the development of proteins. It will be a valuable resource for those interested in using phage display and recombinant antibodies in basic research and drug discovery. Key Features: Describes the basic principles of phage display and the methods and systems that have been developed for key applications Outlines applications for peptide phage display in the development of vaccines and high- throughput screens as well as the exploration of protein-protein interactions and enzyme substrate characteristics Details the use of phage display in the engineering of protein stability, the identification and mapping of protein-protein interactions, and the development of catalysts Provides broad coverage of the impact of phage display technology on the development of protein therapeutics Presents expert opinions on future challenges in the field

In 1993, the genetic mutation responsible for Huntington's disease (HD) was identified. Considered a milestone in human genomics, this discovery has led to nearly two decades of remarkable progress that has greatly increased our knowledge of HD, and documented an unexpectedly large and diverse range of biochemical and genetic perturbations that seem to result directly from the expression of the mutant huntingtin gene. Neurobiology of Huntington's Disease: Applications to Drug Discovery presents a thorough review of the issues surrounding drug discovery and development for the treatment of this paradigmatic neurodegenerative disease. Drawing on the expertise of key researchers in the field, the book discusses the basic neurobiology of Huntington's disease and how its monogenic nature confers enormous practical advantages for translational research, including the creation of robust experimental tools, models, and assays to facilitate discovery and validation of molecular targets and drug candidates for HD. Written to support future basic research as well as drug development efforts, this volume: Covers the latest research approaches in genetics, genomics, and proteomics, including high-throughput and high-content screening Highlights advances in the discovery and development of new drug therapies for neurodegenerative disorders Examines the practical realities of preclinical testing, clinical testing strategies, and, ultimately, clinical usage While the development of effective drug treatments for Huntington's disease continues to be tremendously challenging, a highly interactive and cooperative community of researchers and clinical investigators now brings us to the threshold of potential breakthroughs in the quest for therapeutic agents. The impressive array of drug discovery resources outlined in the text holds much promise for treating this devastating disease, providing hope to long-suffering Huntington's disease patients and their families.

How do we know whether a particular treatment really works? How reliable is the evidence? And how do we ensure that research into medical treatments best meets the needs of patients? These are just a few of the questions addressed in a lively and informative way in Testing Treatments. Brimming with vivid examples, Testing Treatments will inspire both patients and professionals. Building on the success of the first edition, Testing Treatments has now been extensively revised and updated. The Second Edition includes a thought-provoking chapter on screening, explaining why early diagnosis is not always better. Other new chapters explore how over-regulation of research can work against the best interests of patients, and how robust evidence from research can be drawn together to shape the practice of healthcare in ways that allow treatment decisions to be reached jointly by patients and clinicians. Testing Treatments urges everyone to get involved in improving current research and future treatment, and outlines practical steps that patients and doctors can take together.

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... -international regulation and deregulation -venture capitalist investment -the IND process -informed consent -changes in manufacturing and updated and extended coverage of... -pediatric drug trial design -the advantages and disadvantages of orphan drug designations -the maximization of package inserts for marketing -post approval safety surveillance -withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Study the latest research findings by international experts This comprehensive volume presents state-of-the-art scientific research on the therapeutic uses of cannabis and its derivatives. All too often, discussions of the potential medical uses of this substance are distorted by political considerations that have no place in a medical debate. Cannabis and Cannabinoids: Pharmacology, Toxicology, and Therapeutic Potential features fair, equitable discussion of this emerging and controversial medical topic by the world's foremost researchers. Cannabis and Cannabinoids examines the benefits, drawbacks, and side effects of medical marijuana as a treatment for various conditions and diseases. This book discusses the scientific basis for marijuana's use in cases of pain, nausea, anorexia, and cachexia. It also explores its possible benefits in glaucoma, ischemia, spastic disorders, and migraine. Cannabis and Cannabinoids examines all facets of the medical use of marijuana, including: botany history biochemistry pharmacology clinical use toxicology side effects Cannabis and Cannabinoids is a reference work that will become indispensable to physicians, psychologists, researchers, biochemists, graduate students, and interested members of the public. No other book available offers this comprehensive, even-handed look at a deeply divisive subject.

Obtaining good quality oocytes and preparing them for in-vitro fertilization (IVF) is a key stage in assisted reproduction. This is a complex process with many pitfalls, making good clinical preparation and laboratory technique essential for success. Illustrated throughout, this book will be valuable to clinical embryologists, laboratory personnel wishing to redefine or develop technique and improve outcomes, IVF quality managers, and gynecologists performing oocyte retrieval. Featuring descriptions of the underlying science along with practical advice on methods and trouble-shooting, this comprehensive manual will aid all those involved in this complex process of oocyte retrieval and preparation in navigating towards optimal outcomes.

From 1932 to 1972, the United States Public Health Service conducted a non-therapeutic experiment involving over 400 black male sharecroppers infected with syphilis. The Tuskegee Study had nothing to do with treatment. It purpose was to trace the spontaneous evolution of the disease in order to learn how syphilis affected black subjects. The men were not told they had syphilis; they were not warned about what the disease might do to them; and, with the exception of a smattering of medication during the first few months, they were not given health care. Instead of the powerful drugs they required, they were given aspirin for their aches and pains. Health officials systematically deceived the men into believing they were patients in a government study of "bad blood", a catch-all phrase black sharecroppers used to describe a host of illnesses. At the end of this 40 year deathwatch, more than 100 men had died from syphilis or related complications. "Bad Blood" provides compelling answers to the question of how such a tragedy could have been allowed to occur. Tracing the evolution of medical ethics and the nature of decision making in bureaucracies, Jones attempted to show that the Tuskegee Study was not, in fact, an aberration, but a logical outgrowth of race relations and medical practice in the United States. Now, in this revised edition of "Bad Blood", Jones traces the tragic consequences of the Tuskegee Study over the last decade. A new introduction explains why the Tuskegee Study has become a symbol of black oppression and a metaphor for medical neglect, inspiring a prize-winning play, a Nova special, and a motion picture. A new concluding chapter shows how the black community's wide-spread anger and distrust caused by the Tuskegee Study has hampered efforts by health officials to combat AIDS in the black community. "Bad Blood" was nominated for the Pulitzer Prize and was one of the "N.Y. Times" 12 best books of the year.

Data Monitoring in Clinical Trial: A Practical Perspective ist die erweiterte 2. Auflage des weit verbreiteten und viel beachteten Fachbuchs, das erstmals im Jahr 2002 erschienen ist. Es bietet einen fundierten und aktuellen UEberblick uber Datenkontrollkomitees, deren Einrichtung, Zweck und Zustandigkeiten. - Enthalt direkt umsetzbare Handreichungen fur alle, die klinische Studien verwalten und durchfuhren, sowie fur Mitglieder von Datenkontrollkomitees. - Liefert Mitgliedern von Behoerden- und Ethikkommissionen Einblicke in die Kontrolle klinischer Daten. - Diskutiert Themen mit Relevanz fur diejenigen, die in den USA und in Europa an klinischen Studien arbeiten. Die praktischen Handlungsansatze in diesem Buch sind fur Experten aus dem akademischen Bereich, bei Regierungsstellen und aus der Industrie, vor allem fur Medizinstatistiker, Kliniker, Koordinatoren von klinischen Studien von Nutzen, ob sie Studien durchfuhren und/oder begleiten. Ebenso relevant ist dieses Praktikerbuch fur Mitarbeiter bei Regulierungsstellen und im Bereich der Bioethik.

Arguably the first book of its kind, Computational Bioengineering explores the power of multidisciplinary computer modeling in bioengineering. Written by experts, the book examines the interplay of multiple governing principles underlying common biomedical devices and problems, bolstered by case studies. It shows you how to take advantage of the latest computational capabilities to deal with biomedical problems using an integrative approach. This approach fosters an integrative problem-solving mentality for the generation of new and novel solutions to future biomedical problems. Each chapter begins with a brief review of the advances in computational efforts in the selected topic area and ends with case studies with detailed technical information. The approach provides a relevant overview of the selected topic area and demonstrates, with case studies, the power of computational modeling in offering predictive capabilities to assess new surgical concepts and medical devices and post-operative surgical outcomes. The book illustrates the expanded capabilities of computational bioengineering through discussions of bioengineering problems and discusses an image-based bioengineering modeling technique. Although computer modeling has been used to tackle bioengineering problems for decades, a systematic study of computational bioengineering not only addresses many critical challenges facing bioengineering but also sets a new direction for advancing the field. In a long run, this book is expected to foster an integrative problem-solving mentality that will help you generate new and novel solutions to future biomedical problems.

This unique book draws on research that constituted the first major nationwide evaluation of the use and impact of key digital health information platforms which were provided to thousands of health consumers in the UK. The authors offer the first comprehensive and detailed comparison of usage and impact of the three major ICT platforms delivering health information - the internet, touch-screen kiosks and digital interactive television. It provides an extensive reference source on how health consumers behave when online, whether this differs according to digital platform or type of user, how users perceive digital health services and what health benefits these services deliver. The book will be invaluable reading for all those interested in digital health information - students, academics, health policy-makers and information managers.

This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

Public health researchers and clinicians regularly work with people who have suffered physical and mental trauma. Knowing how to conduct a study or treat a patient while navigating deep emotional issues requires special skills and overall awareness of how trauma can impact the process and outcomes of participating in research and/or receiving health care. This book presents a diverse array of case examples from scholars of health-related topics, focusing on biographical narrative as a window into understanding key needs in trauma informed scholarship and medicine. Exploring stories from people of varied backgrounds, experiences, and contexts can help professionals within and beyond the academic research and clinical care spheres create rewarding experiences for patients. Negotiating the Emotional Challenges of Conducting Deeply Personal Research in Health will be of interest to public health practitioners, educators and researchers as well as students.

Undue Risk is an unprecedented and chilling history of the use of human subjects in atomic, biological and chemical warfare experiments by the US Government from World War II to the present. Jonathan Moreno, a senior researcher on the President's special commission, goes where few researchers have gone before, exploring secret government documents which reveal a plethora of government experiments.
Now available in paperback, with a new afterword, this exciting read covers recent objections by US military personnel to required anthrax vaccinations and new developments in government policies on experiments involving vulnerable human subjects.