The FDA sets policy and formulates rules and regulations governing how new drugs, medical devices, and more are developed, approved, and brought to market. The scope of the US Food and Drug Administration's regulatory authority is very broad, and includes:
Additional videos on numerous relevant topics are available from HSTalks: Biomedical & Life Sciences Collection.
Artificial Intelligence and Precision Oncology: Bridging Cancer Research and Clinical Decision Support by
This book highlights the use of artificial intelligence (AI), big data and precision oncology for medical decision making in cancer screening, diagnosis, prognosis and treatment. Precision oncology has long been thought of as ideal for the management and treatment of cancer. This strategy promises to revolutionize the treatment, control, and prevention of cancer by tailoring tests, treatments and predictions to specific individuals or population groups. In order to accomplish these goals, vast amounts of patient or population group specific data needs to be integrated and analysed to be able to identify key patterns or features which can be used to define or characterize the disease or the response to the disease in these individuals. These patterns or features can be as varied as molecular patterns or features in medical images. This level of data analysis and integration can only be achieved through the use of AI. The book is divided into three parts starting with a section on the use of artificial intelligence for screening, diagnosis and monitoring in precision oncology. The second part: Artificial intelligence and Omics in precision oncology, highlights the use of AI and epigenetics, metabolomics, microbiomics in precision oncology. The third part covers artificial intelligence in cancer therapy and its clinical applications. It also highlights the use of AI tools for risk prediction, early detection, diagnosis and accurate prognosis. This book, written by experts in the field from academia and industry, will appeal to cancer researchers, clinical oncologists, pathologists, medical students, academic teaching staff and medical residents interested in cancer research as well as those specialising as clinical oncologists.
Artificial Intelligence in Digital Holographic Imaging by
Artificial Intelligence in Digital Holographic Imaging Technical Basis and Biomedical Applications An eye-opening discussion of 3D optical sensing, imaging, analysis, and pattern recognition Artificial intelligence (AI) has made great progress in recent years. Digital holographic imaging has recently emerged as a powerful new technique well suited to explore cell structure and dynamics with a nanometric axial sensitivity and the ability to identify new cellular biomarkers. By combining digital holography with AI technology, including recent deep learning approaches, this system can achieve a record-high accuracy in non-invasive, label-free cellular phenotypic screening. It opens up a new path to data-driven diagnosis. Artificial Intelligence in Digital Holographic Imaging introduces key concepts and algorithms of AI to show how to build intelligent holographic imaging systems drawing on techniques from artificial neural networks, convolutional neural networks, and generative adversarial network. Readers will be able to gain an understanding of the basics for implementing AI in holographic imaging system designs and connecting practical biomedical questions that arise from the use of digital holography with various AI algorithms in intelligence models. What's Inside Introductory background on digital holography Key concepts of digital holographic imaging Deep-learning techniques for holographic imaging AI techniques in holographic image analysis Holographic image-classification models Automated phenotypic analysis of live cells For readers with various backgrounds, this book provides a detailed discussion of the use of intelligent holographic imaging system in biomedical fields with great potential for biomedical application.
Biochips and Medical Imaging by
Advanced, recent developments in biochips and medical imaging Biochips and Medical Imaging is designed as a professional resource, covering recent biochip and medical imaging developments. Within the text, the authors encourage uniting aspects of engineering, biology, and medicine to facilitate advancements in the field of molecular diagnostics and imaging. Biochips are microchips for efficiently screening biological analytes. This book aims at presenting information on the state-of-the-art and emerging biosensors, biochips, and imaging devices of the body's systems, including the endocrine, circulatory, and immune systems. Medical diagnostics includes biochips (in-vitro diagnostics) and medical and molecular imaging (in-vivo imaging). Biochips and Medical Imaging explores the role of in-vitro and in-vivo diagnostics. It enables an instructor to share in-depth examples of the use of biochips in diagnosing cancer and cardiovascular diseases.  Provides real-life knowledge on biochips and medical imaging, written by leading researchers Serves as a resource for professionals working in the biochip or imaging fields Features an accessible approach for anyone interested in biochips and their applications Readers of Biochips and Medical Imaging can expand their knowledge of medical technology, even if they have no biological knowledge and a limited math background. With its focus on important developments, this book is sure to also capture the interest of bioengineering and biomaterials scientists, structural biologists, electrical engineers, and nanotechnologists.
Biomarkers in Cancer Detection and Monitoring of Therapeutics by
Molecular Biomarkers in Cancer Detection and Monitoring of Therapeutics, Volume One, Discovery and Technologies discusses how molecular biomarkers are used to determine predisposition, facilitate detection, improve treatment and offer prevention guidelines for different cancer types. This first volume in the series focuses on techniques and approaches recently developed to assist in the decision of which biomarker to use for specific conditions. Topics covered include circulating tumor cells and circulating tumor DNA, exomes, tumor microenvironment, gene editing, artificial intelligence and robotics. In addition, the book discusses the development and applications of organoids and precision medicine.This book will be a valuable resource for cancer researchers, oncologists, graduate students and members of the biomedical field who are interested in the potential of biomarkers in cancer research. Provides up-to-date information on current molecular biomarkers research for cancer Presents basic research aspects and novel technologies applied in the discovery of new biomarkers Discusses several technologies, including artificial intelligence, robotics, data mining, gene editing, omics and their applicability for specific cancer types
Bringing Medical Devices to Market by
The medical device industry has experienced tremendous innovation and growth in recent years, with more than 200 million medical devices in use globally. For those seeking to bring medical devices to market, this exciting expansion also comes with pronounced risks and challenges, particularly on the legal front. Authored by experts with decades of collective expertise and familiarity with both government and private sectors, Bringing Medical Devices to Market will guide practitioners and professionals on the entire process, covering intellectual property issues at proof-of-concept stage, regulatory barriers, rules of engagement regarding promotion, contract considerations, compliance in all phases, and more.
The Convergence of Human and Artificial Intelligence on Clinical Care - Part I by
This edited book contains twelve studies, large and pilots, in five main categories: (i) adaptive imputation to increase the density of clinical data for improving downstream modeling; (ii) machine-learning-empowered diagnosis models; (iii) machine learning models for outcome prediction; (iv) innovative use of AI to improve our understanding of the public view; and (v) understanding of the attitude of providers in trusting insights from AI for complex cases. This collection is an excellent example of how technology can add value in healthcare settings and hints at some of the pressing challenges in the field. Artificial intelligence is gradually becoming a go-to technology in clinical care; therefore, it is important to work collaboratively and to shift from performance-driven outcomes to risk-sensitive model optimization, improved transparency, and better patient representation, to ensure more equitable healthcare for all.
Development of Bio-Based Materials: Synthesis, Characterization and Applications by
The need to find suitable biomaterials and procedures from alternative sources able to imitate or even enhance the performance of currently used products has become an important focus of research today due to the depletion of non-renewable resources and the increasing concern related to climate change, sustainability and environmental preservation. Thus, this reprint gathers different original articles and review manuscripts from the Special Issue “Development of Bio-Based Materials: Synthesis, Characterization and Applications”. The development of partial or fully bio-based materials has been included, with excellent outcomes in many different applications, as well as alternative procedures that can reduce the carbon footprint or optimize both production and energy consumption.
Frontiers of Artificial Intelligence in Medical Imaging by
This book is designed to consider the recent advancements in hospitals to diagnose various diseases accurately using AI-supported detection procedures. This work examines recent AI-supported disease detection techniques from prominent researchers and clinicians working in the medical imaging processing domain. Within this book, the integration of various AI methods, such as soft computing, machine learning, deep learning, and other related works will be presented. Real clinical images utilizing AI are incorporated. The book also includes several chapters on machine learning, convoluted neural networks, segmentation, and deep learning-assisted two-class and multi-class classification. Key Features: Implementation of machine-learning-assisted disease detection Implementation of CNN (Convolutional Neural Networks) based medical image segmentation and assessment Implementation of deep-learning-based medical data assessment Hybridizing machine learning and deep learning features to enhance detection accuracy
Handbook of Medical Device Regulatory Affairs in Asia by
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Medical Device Design: Innovation from concept to market by
Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns
Medical Device Quality Management Systems: strategy and techniques for improving efficiency and effectiveness by
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans
Novel Platforms for Drug Delivery Applications by
Novel Platforms for Drug Delivery Applications covers diverse aspects in the design, synthesis and characterization of novel drug delivery platforms and devices. This book comprehensively details the development, application and performance of various novel molecular frameworks as potent drug delivery vehicles. Chapters cover a range of materials and molecular platforms for drug delivery, from hydrogels, nanocarriers and metal-organic-frameworks, to ?-cyclodextrin and polyphosphazene. Each chapter discusses the benefits and limitations of each drug delivery system, as well as toxicological and safety implications. This book offers an interdisciplinary approach to this fast-moving topic, bridging the disciplines of materials science and pharmacology. Provides an up-to-date single resource on novel drug delivery platforms, a rapidly evolving field of research Covers a broad range of materials, systems and release mechanisms, including in vivo and in vitro studies Describes the synthesis, properties, formulation and application of various novel drug delivery systems
Overcoming Obstacles in Drug Discovery and Development: Surmounting the Insurmountable - Case Studies for Critical Thinking by
Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development.
An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco by
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful.
Pharmacoepidemiology, 6th edition by
This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Principles of Protein-Protein Association by
Protein-protein associations are fundamental to biological mechanisms. This book, created from lecture notes and classroom sessions, covers the general principles of protein-protein association. It should be of considerable value to cell biologists with a limited understanding of proteins, as well as to biochemists with a deeper background in protein structure. Developed from lectures given to beginning graduate students in cell and molecular biology, Principles of Protein-Protein Association presents general principles of thermodynamics and kinetics, and structural principles of protein-protein interface. An important feature is guided reading of informative classic papers. Faculties organizing similar classes, and students and researchers wishing to learn on their own, will also find this book of use. Book jacket.
Progress in Nanomedicine in Neurologic Diseases by
This book covers the use of nanomedicine in the delivery of neuroprotective agents, including pharmacological drugs, stem cells, neurotrophic factors, monoclonal antibodies and enzymes to induce greater beneficial effects in neurologic diseases. Thus, the main purpose of the book is to explore the delivery of drugs either alone or in combination with stem cells to enhance neuroprotection in neurological diseases. Brain pathology associated with acute trauma such as head injury and brain blast injury can also be managed using novel treatment strategies. In addition, emphasis is made that standard patterns of brain pathology may be complicated with multiple comorbidity factors where one agent alone is not sufficient to induce brain protection. Enzymes and antibodies may help in combination and enhance the efficacy when administered through nanotechnology. Progress in Nanomedicine in Neurologic Diseases will encourage further research in the field of neuroprotection, brain injury, neurodegenerative diseases, neuropharmacology, neuropathology, and neurology. Students and researchers along with policy makers, teachers and health care professionals may also benefit from the findings of the book for enhanced patients care.
Regulatory Affairs in the Pharmaceutical Industry by
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.
Translational Biotechnology: a journey from laboratory to clinics by
Translational Biotechnology: A Journey from Laboratory to Clinics presents an integrative and multidisciplinary approach to biotechnology to help readers bridge the gaps between fundamental and functional research. The book provides state-of-the-art and integrative views of translational biotechnology by covering topics from basic concepts to novel methodologies. Topics discussed include biotechnology-based therapeutics, pathway and target discovery, biological therapeutic modalities, translational bioinformatics, and system and synthetic biology. Additional sections cover drug discovery, precision medicine and the socioeconomic impact of translational biotechnology. This book is valuable for bioinformaticians, biotechnologists, and members of the biomedical field who are interested in learning more about this promising field. Explains biotechnology in a different light by using an application-oriented approach Discusses practical approaches in the development of precision medicine tools, systems and dynamical medicine approaches Promotes research in the field of biotechnology that is translational in nature, cost-effective and readily available to the community
Virtual Reality in Behavioral Neuroscience: New Insights and Methods by
Virtual Reality (VR) is a rapidly maturing technology that offers new and unique solutions to otherwise intractable problems in the study of cognition, behavior and neuroscience. VR removes many of the constraints imposed by laboratory paradigms, allowing us to track cognitive, behavioral and brain responses to naturalistic (or even impossible) situations without sacrificing experimental control. But VR is not a tool that can be swiftly and effortlessly integrated into existing research pipelines; currently, the benefits of VR are accompanied by a host of methodological challenges and important practical considerations. To help navigate this new methodology, this volume provides a balanced review of both the exciting new findings emerging from VR labs and the challenges and limitations that are part and parcel of VR research. This volume is an important first step toward establishing a standardised methodology for conducting research in VR. To this end, the volume provides a wealth of practical advice for researchers who are new to the technology. This volume is authored by an interdisciplinary team of VR researchers including computer scientists, engineers, psychologists and neuroscientists. It highlights current research in the field to demonstrate how VR advances our understanding of the mind, while also providing groundbreaking solutions in applied domains.
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Collection of 11 videos (with PDFs of slides) from The Biomedical & Life Sciences Collection, Henry Stewart Talks on topics such as:
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOPs) provide the main forum for the documentation of a pharmaceutical company's systems and operations and compliance with GXP such as GCP, GPV, GMP and GLP.
