This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

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.

This book provides readers with an integrative overview of the latest research and developments in the broad field of biomedical engineering. Each of the chapters offers a timely review written by leading biomedical engineers and aims at showing how the convergence of scientific and engineering fields with medicine has created a new basis for practically solving problems concerning human health, wellbeing and disease. While some of the latest frontiers of biomedicine, such as neuroscience and regenerative medicine, are becoming increasingly dependent on new ideas and tools from other disciplines, the paradigm shift caused by technological innovations in the fields of information science, nanotechnology, and robotics is opening new opportunities in healthcare, besides dramatically changing the ways we actually practice science. At the same time, a new generation of engineers, fluent in many different scientific "languages," is creating entirely new fields of research that approach the "old" questions from a new and holistic angle. The book reports on the scientific revolutions in the field of biomedicine by describing the latest technologies and findings developed at the interface between science and engineering. It addresses students, fellows, and faculty and industry investigators searching for new challenges in the broad biomedical engineering fields.

Originally published in 1997 Evolutionary Change addresses the somatic mechanism of change. Although astounding advances in molecular biology have opened up new engineering possibilities to shape our future in terms of "improving" the human species as well as eradicating all kinds of pathological characteristics of biological development, these possibilities pose potentially serious dangers. They arise primarily from the local nature of changes that are introduced and the impact of the environment on the overall development of the biological system. The book explores the biological mechanisms of change in their entirety - as they fit into the general dynamics of biological systems - and demonstrates the pitfalls of tackling change from a narrow perspective, using cancer as an example of certain pathological manifestations of these mechanisms of change.

First published in 1998, this volume examines a major function of research which is to strengthen the knowledge base of health professions and so enhance patient care. The rapid growth has unfortunately led to it being seen by many as an elitist activity full of jargon, carried out by academics. This to some degree has led to a theory practice gap with some professionals not recognising their important role within the research process. It is important to dispel the myth that all practitioner should carry out research, though they should use elements of the research process to develop a questioning and evaluative approach to care. This book will enable reader to demystify and enhance their understanding of terminology used in research and contains almost 300 terms. It offers readers a unique approach to explanations for each term by offering its Everyday use; its Research use; an Example and Related terms.

This book provides deep insight into the significance of various forensic techniques underlying the methodical approaches in criminal investigations. The book comprises numerous case studies, examples, and reference materials. It emphasizes on the better practices for criminal investigations including contemporary examinations. The book also describes various methods for investigation of crime scene and evidence collection including biological evidences to the resources of law enforcement agencies. This book encompasses the procedure for crime scene-documentation through photography, video, and diagrams and highlights the best practices of packaging the biological evidences at a crime scene. Further, it summarizes the role of forensic autopsy to the criminal investigation system. As such, the book is helpful for forensic scientists, medical practitioners, educators and law enforcement personnel.

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.

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.

Cell biology is a rapidly advancing subject. Understanding principles of nuclear architecture is a key question. Researchers are starting to develop more strict and rigorous methods of image processing and quantitative analysis to provide an end-to-end process supporting the fundamental biology.

This book has chapters contributed by experts in the field that address the whole endeavour of teasing out the principles of nuclear architecture: ranging from fundamental science, through imaging processing and quantitative analysis, to applications, related to disease. This material is focussed on the latest breakthroughs, and moreover will emphasise a strict and rigorous development of the scientific process. A systems view is stressed where relevant. The objective is not to provide an encyclopaedic compendium of nuclear architecture information, but rather to present state of the art tools in specific contexts, which will readily generalise.

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.

Open Access Data is emerging as a source for cutting edge scholarship. This concise book provides guidance from generating a research idea to publishing results. Both young researchers and well-established scholars can use this book to upgrade their skills with respect to emerging data sources, analysis, and even post-publishing promotion. At the end of each chapter, a tutorial simulates a real example, allowing readers to apply what they learned about accessing open data, and analyzing this data to reach the results. This book can be of use by established researchers analyzing data, publishing, and actively promoting ongoing and research. Key selling features: Describes the steps, from A-Z, for doing open data research Includes interactive tutorials following each chapter Provides guidelines for readers so that they can use their own accessed open data Reviews recent software and websites promoting and enabling open data research Supplements websites which update recent open data sources

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.

This title was first published in 2003: As new medical technologies and treatments develop with increasing momentum, the legal and ethical implications of research involving human participants are being called into question as never before. Human Experimentation and Research explores the philosophical foundations of research ethics, ongoing regulatory dilemmas, and future challenges raised by the rapid globalisation and corporatisation of the research endeavour. This volume brings together some of the most significant published essays in the field. The editors also provide an informative introduction, summarizing the area and the relevance of the articles chosen.

A major objective of this book is to reveal unprecedented opportunities to understand and overcome drug resistance through the clinical assessment of rational therapeutic drug combinations and the use of predictive and prognostic biomarkers to enable patient stratification and tailor treatments. It offers to the readers an updated overview on the possible reasons of failure of new and promising therapeutic opportunities.

Uniquely organized to help readers find and select the best frameworks for their needs This resource illuminates the daunting task of understanding and applying philosophies, models, theories, and taxonomies in nursing practice and research at the masters or doctoral level. Distinguished by a unique organizational structure, the text is divided into two broad areas of practice/focus; individuals and families (Part II) and communities, populations, and systems (Part III). The frameworks in each area are organized conceptually into 17 chapters, many of which are interdisciplinary, thus not commonly found in nursing theory texts. This unique organizational structure enables readers to acquire both a broad overview of frameworks useful in nursing practice and research, and to focus on frameworks relevant to specific practice areas and concepts of interest. Frameworks for Advanced Nursing Practice and Research also provides foundational knowledge to enhance the nurse's understanding and appreciation of frameworks used in practice and research (Part 1). Application is woven throughout the text and culminates with chapters devoted to the application of frameworks for nurse educators, clinicians, leaders, and researchers. Learner-focused features of the text include application boxes highlighting published studies that have employed selected frameworks, thereby bringing theoretical content into practice. Each chapter also includes objectives, key terms, and a bulleted summary to enhance the learning experience. Key Features: Describes a broad spectrum of philosophies, models, theories, and taxonomies underpinning graduate-level nursing roles Uniquely organized by conceptual areas, thereby integrating nursing and non-nursing frameworks Facilitates easy comparison of frameworks within each conceptual area Delivers strategies for using theory and discusses integration of theory, research, and practice Includes application boxes highlighting published studies, objectives, key terms, and bulleted chapter summary.

The Biomaterials Science and Engineering Series is designed to help stimulate further developments in biomaterials science and engineering by disseminating up-to-the-minute, quality information to academic and industrial research and development scientists employed in all areas of the medical, biomedical and bioengineering sciences whether in medical device R&D, pharmaceutical and pharmacological research or materials science, and to clinical specialists in prosthetics and surgery.

Contrary to popular belief, the future for metals and alloys as biomaterials is strong. State-of-the-art engineering methods, combined with the intrinsic strengths of metals, have resulted in considerably improved and new types of medical device. This timely reference provides a detailed appraisal of:

• biomaterial selection, with emphasis on mechanical strength, fatigue resistance and fracture toughness

• the inherent shortcomings of metals and how best to deal with them

• shape memory alloys

• surface treatment, thin organic coatings, and polymer—metal macrocomposites

• tissue—implant interactions and biocompatibility

• x-ray photoelectron spectroscopy and electrochemical impedance spectroscopy

This landmark annual review has provided nearly three decades of knowledge, insight, and research on topics critical to nurses everywhere.

The purpose of this annual review is to critically examine the full gamut of literature on key topics in nursing practice, including nursing theory, care delivery, nursing education, and the professional aspects of nursing.

Past volumes of "Annual Review of Nursing Research" have addressed critical issues such as: Chronic illness Geriatrics Alcohol abuse Patient safety Rural nursing Tobacco use Nursing workforce issues Genetics

For the first time ever, we invite readers to purchase either individual issues of this annual review, or to subscribe to the complete periodical and gain access to all previously published and forthcoming issues.

This book is a simple guide to the diagnosis, investigation, and treatment of all gynaecological cancers. It discusses the management of patients with gynaecological malignancies; considers the principles of chemotherapy, radiotherapy, and surgery; explains when and why each modality is used in treatment; covers the pathology of gynaecological cancer; discusses treatment of the advanced disease; and includes a chapter on the role of palliative care. The multidisciplinary approach reflects the cooperative practice in combined clinics.

Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:

Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines

Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures

Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers

This book is a useful resource to scientists and researchers in bothindustry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development."

This inspirational text will appeal to those both starting research projects and those wanting to understand how research can be used in everyday working practice. It brings together expertise from a wide range of areas and makes research easy and accessible. The practical workbook style is easy to use and shows the whole process from design to dissemination and application. Those working in primary healthcare teams and the new organisations supporting them will find it essential reading. Primary Care Research series is aimed at developing the knowledge, expertise and skills of all practitioners in primary care. Each book is based on contributions from experts in their field and is supported by practical facts, personal insight, support and advice. They enable all primary care practitioners to realise the potential of exploring information used in everyday working practice. Other books in the Primary Care Research series: Wilson: Research Approaches in Primary Care Mathers: Statistical Analysis in Primary Care

This narrative of a cancer researcher spans a period in which biomedicine research has been so revolutionary. The educational background and socioeconomic circumstances of the author make the story unique, shedding light on many important intellectual achievements. The author also provides an insightful view on how decisions at the upper echelon of scientific institutions affect cancer researchers. The vivid account of scientific discovery and intellectual evolution provides a fine example for the next generation of cancer researchers.

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.

New Developments in Dementia Prevention Research addresses a dearth of knowledge about dementia prevention and shows the importance of considering the broader social impact of certain risk factors, including the role we each play in our own cognitive health throughout the lifespan. The book draws on primary and secondary research in order to investigate the relationship between modifiable factors, including vascular and psychosocial risks, that may affect the incidence of dementia. Bringing together world-leading expertise from applied science, medicine, psychology, health promotion, epidemiology, health economics, social policy and primary care, the book compares and contrasts scientific and service developments across a range of settings. Each chapter presents these themes in a way that will ensure best practice and further research in the field of dementia prevention is disseminated successfully throughout the world. Perhaps most importantly, chapters also question what type of social responsibility we are prepared to embrace in order to address the challenges inherent in dementia prevalence. New Developments in Dementia Prevention Research includes contributions from leading authorities in brain health and dementia prevention and provides an essential contribution to the discourse on dementia prevention. It will be of great interest to academics, researchers and postgraduate students engaged in the study of the psychological and social aspects of aging and dementia.