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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
by Douglas J. Pisano David S. MantusExamines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
FDA Regulatory Affairs: Third Edition
by David Mantus Douglas J. PisanoFDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
by Cohen Lynch Holly Fernandez I. GlennIn its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
FDA-Speak: A Glossary and Agency Guide
by Dean E. SnyderOften thought of as a subdialect of American "governmentese," FDA-Speak is a language unique to healthcare regulators and those regulated. If you have any involvement with the US Food and Drug Administration, or if they have involvement with you, you need to speak the language. This revised and updated edition of FDA-Speak retains the original easy
FDG PET/CT in Clinical Oncology
by Stanley J. Goldsmith Jasna Mihailovic Ronan P. KilleenFDG PET/CT has rapidly emerged as an invaluable combined imaging modality that provides both anatomic and functional information. This book, comprising a collection of images from oncology cases, is organized according to the role of FDG PET/CT in the evaluation and management of oncology patients, and only secondarily by organ or tumor entity. In this way, it reflects the issues that clinicians actually address, namely: identification of an unknown or unsuspected primary; determination of the extent of disease; evaluation of response to therapy; and surveillance after response, i.e., detection of recurrent disease. In total, 100 cases involving different primary tumors are presented to illustrate findings in these different circumstances. FDG PET/CT in Clinical Oncology will be of great value to all newcomers to this field, whether medical students, radiology, nuclear medicine, or oncology fellows, or practicing physicians.
FDI, Technology and Innovation
by K. Narayanan N. S. SiddharthanThis book concentrates on major changes that are now taking place in the fields of technology, foreign direct investment (FDI), trade and development strategies, with a particular focus on India. Arguably, these changes are likely to differ from those that the world has experienced over the past few decades; in particular, now that many countries have globalised their economies. The book begins by reviewing the changing pattern of FDI flows and technologies among developed and emerging economies, before identifying the determinants of this change by presenting specific studies on Indian industries. It then addresses key questions such as: How are knowledge spillover mechanisms operationalised, and what are the implications of the internationalisation of the IPR process? The role of FDI is also analysed in order to make policy recommendations for fostering innovation in emerging economies like India. The respective chapters examine the process through which technological paradigm and trajectory shifts are taking place, the factors that facilitate such shifts, the changing pattern of FDI, and the shifting focus of international trade and development strategies – four broad themes that are interrelated and mutually reinforcing. The book offers important takeaways for all social scientists, technologists and business schools interested in Indian studies; it will also benefit researchers whose work involves development economics, industrial organisation and technology, and the economy / society interface.
FDR and Civil Aviation
by Alan P. DobsonThe aim of this study is to demonstrate that Franklin D. Roosevelt was one of the leading agents in both setting out and working to implement the principles that came to govern the international aviation system from 1945 down to the recent present and that much of its design was drawn from the experience of domestic US aviation reform in the 1930s. In contemporary parlance one might say that what is proposed here is the explanation of the genesis of a roadmap set out successively by Roosevelt's administrations for the achievement of a liberalized and lightly regulated international civil aviation market. Furthermore, a key contention of this research is that FDR himself played a much more important role in crafting policy than has previously been acknowledged.
FDTD Analysis of Guided Electromagnetic Wave Interaction with Time-Modulated Dielectric Medium (SpringerBriefs in Electrical and Computer Engineering)
by Debdeep SarkarThis book presents a detailed analytical and computational electromagnetic (CEM) treatment of guided electromagnetic (EM) wave propagation in independently time-varying dielectric medium, using the finite-difference time-domain (FDTD) simulation technique. The contents provide an extensive literature review, explaining the importance of time-varying media (temporal photonic crystals) in new exotic applications that involve rich EM phenomena such as parametric amplification, frequency conversion, non-reciprocal gain, electromagnetic energy accumulation, temporal coating and temporal aiming (beam-forming). A one-dimensional (1D) FDTD simulation paradigm is then formulated in this book, starting from Maxwell's equations and boundary conditions. The issues of hard/soft source realizations, perfectly matched layers (PMLs), choice of simulation parameters (cell-size and time-stepping) are thoroughly explained through new visualization tools. This book provides a unique combination of rigorous analytical techniques, several FDTD simulation examples with reproducible source-codes, and new visualization/post-processing mechanisms. The contents of this book should prove to be useful for students, research scholars, scientists and engineers, working in the field of applied electromagnetics, and aiming to design cutting-edge microwave/optical devices based on time-varying medium.
FEM Analysis of the Human Knee Joint: A Review (SpringerBriefs in Applied Sciences and Technology)
by João Manuel R.S. Tavares Zahra Trad Abdelwahed Barkaoui Moez ChafraIn recent years, numerous scientific investigations have studied the anatomical, biomechanical and functional role of structures involved in the human knee joint. The Finite Element Method (FEM) has been seen as an interesting tool to study and simulate biosystems. It has been extensively used to analyse the knee joint and various types of knee diseases and rehabilitation procedures such as the High Tibial Osteotomy (HTO). This work presents a review on FEM analysis of the human knee joint and HTO knee surgery, and discusses how adequate this computational tool is for this type of biomedical applications. Hence, various studies addressing the knee joint based on Finite Element Analysis (FEA) are reviewed, and an overview of clinical and biomechanical studies on the optimization of the correction angle of the postoperative knee surgery is provided.
FEM and Micromechatronics with ATILA Software
by Kenji UchinoStudents preparing to work with mechatronics, particularly with highly precise and smart actuators, face the challenge of designing and analyzing devices without formal and practical guidance in computer techniques. Finally there is a textbook that is as practical as it is authoritative: Kenji Uchino's FEM and Micromechatronics with ATILA Software.Ideal for Today's Computer-Based CurriculaEvery aspect of this book reflects its focus on being easy to use, easy to teach from, and above all, easy to implement. The first half of the text outlines the theory needed to develop and design smart actuators and transducers, while the second half walks students step-by-step through the software implementation using seven extensive examples. Even the book's lay-flat binding makes it easy for students to follow the text while working simultaneously at a computer. The companion CD-ROM supplies a free educational version of ATILA-Light.Unified Coverage for Integrated TechnologiesCovering the myriad challenges posed by smart transducers, the author introduces the fundamentals of piezoelectric and magnetostrictive devices, practical materials, device designs, drive and control techniques, and typical applications. Numerous problems and examples give students ample opportunity to put the concepts into practice.Outlining a complete treatment in 30 convenient 75 minute lessons, FEM and Micromechatronics with ATILA Software is a unique classroom text that students will continue to use throughout their entire careers.
FIB Nanostructures
by Zhiming M. WangFIB Nanostructures reviews a range of methods, including milling, etching, deposition, and implantation, applied to manipulate structures at the nanoscale. Focused Ion Beam (FIB) is an important tool for manipulating the structure of materials at the nanoscale, and substantially extends the range of possible applications of nanofabrication. FIB techniques are widely used in the semiconductor industry and in materials research for deposition and ablation, including the fabrication of nanostructures such as nanowires, nanotubes, nanoneedles, graphene sheets, quantum dots, etc. The main objective of this book is to create a platform for knowledge sharing and dissemination of the latest advances in novel areas of FIB for nanostructures and related materials and devices, and to provide a comprehensive introduction to the field and directions for further research. Chapters written by leading scientists throughout the world create a fundamental bridge between focused ion beam and nanotechnology that is intended to stimulate readers' interest in developing new types of nanostructures for application to semiconductor technology. These applications are increasingly important for the future development of materials science, energy technology, and electronic devices. The book can be recommended for physics, electrical engineering, and materials science departments as a reference on materials science and device design.
FINDING THE PATH: Issues of Access to Research Resources
by Commission on Life SciencesThe National Academies Press (NAP)--publisher for the National Academies--publishes more than 200 books a year offering the most authoritative views, definitive information, and groundbreaking recommendations on a wide range of topics in science, engineering, and health. Our books are unique in that they are authored by the nation's leading experts in every scientific field.
FIRE POWER IN THE LAB: Automation in the Fight Against Infectious Diseases and Bioterrorism
by Scott P. Layne Tony J. Beugelsdijk C. Kumar N. PatelToday's world poses a triple threat to the American population: infectious diseases, contamination of food and water, and bioattacks (biowarfare or bioterrorism). At least 17 countries are producing weapons of mass destruction using viruses, bacteria, or their toxins. AIDS, E. coli contamination, drug-resistant tuberculosis, and virulent flu strains are perhaps the best known of a host of disease threats. What these dangers have in common is the amount of data required to achieve solutions; in some cases, as much as a petabit (1 followed by 15 zeros) of data is required to study large numbers of samples from widespread locations.Firepower in the Lab examines how the nation can combat this triple threat by improving our ability to detect, measure, and monitor harmful biological agents. It explores the potential of today's exciting new laboratory automation and computer technologies as well as the emerging tools of molecular biology--how we can generate and analyze more data quickly and reduce human hands-on involvement, which inevitably introduces errors.The book discusses how to improve and apply technologies such as robotics, laboratory automation, "lab-on-a-chip," bioinformatics, and Internet control innovations. It reviews lessons learned from our experience with pandemic flu viruses. It also presents strategies for developing new high-throughput technologies, including how to address the lack of public funding for critical research undertakings.
FLIM Microscopy in Biology and Medicine
by Ammasi Periasamy Robert M. CleggDetecting Signals at the Single Molecule Level: Pioneering Achievements in MicroscopyRecent advances have led to such remarkable improvements in fluorescence lifetime imaging microscopy's (FLIM) capacity for contrast and sensitivity that researchers can now employ it to detect signals at the single molecule level. FLIM also offers the additional be
FND Stories: Personal and Professional Experiences of Functional Neurological Disorder
by Gregg H. Rawlings, Markus Reuber, Jon Stone and Maxanne McCormickFunctional Neurological Disorder (FND) is one of the most common diagnoses among patients referred to neurology clinics, but is still misunderstood and under-recognised by medical professionals and the public. This vital book brings together the voices of healthcare professionals and people living with FND across the world. Experts in neurology provide a clear, evidence-based explanation of FND as an introduction, laying the foundation for the personal stories of people with FND and the professionals involved in their care. From testing and diagnosis to dealing with stigma and coping with changing symptoms, each chapter delves into the realities of life with FND from the perspective of lived experience. FND can be an isolating condition. The life stories in this book will help you to make sense of living with FND and tackle its challenges alongside others with the condition.
FORCEnet: IMPLEMENTATION STRATEGY
by National Research Council of the National AcademiesThe National Academies Press (NAP)--publisher for the National Academies--publishes more than 200 books a year offering the most authoritative views, definitive information, and groundbreaking recommendations on a wide range of topics in science, engineering, and health. Our books are unique in that they are authored by the nation's leading experts in every scientific field.
FORENSICS
by Samuel Carbaugh Carla MooneyForensics: Uncover the Science and Technology of Crime Scene Investigation introduces students to the fascinating world of forensic science and shows them how to find clues, analyze evidence, and crack the case.Combining hands-on activities with forensic science, kids will have fun learning about the world of forensics, evidence collection, and crime lab analysis. Entertaining illustrations and fascinating sidebarsilluminate the topic and bring it to life, reinforcing new vocabulary.Projects include documenting a crime scene, identifying fingerprints, analyzing blood spatter, and extracting DNA. Additional materials include a glossary and a list of current reference works, websites, museums, and science centers.
FOSS Science Resources: Insects and Plants
by Lawrence Hall of Science University of California at BerkeleyNIMAC-sourced textbook
FOSS Science Resources: Pebbles, Sand, and Silt
by Lawrence Hall of Science University of California at BerkeleyNIMAC-sourced textbook
FOSS Science Resources: Solids and Liquids
by Lawrence Hall of Science University of California at BerkeleyNIMAC-sourced textbook
FOXO Transcription Factors: Methods and Protocols (Methods in Molecular Biology #1890)
by Wolfgang LinkThis volume provides an overview of experimental procedures and state-of art methods to investigate FOXOs. Chapters guide readers through biochemical and molecular methods, imaging approaches to monitor the subcellular localization of FOXO factors, omics and bioinformatics approaches, different animal models used in FOXO research, and human studies to investigate the role of FOXO factors in human disease and longevity. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge FOXO Transcription Factors: Methods and Protocols aims to ensure successful results in the further study of this vital field.
FOXO Transcription Factors: Methods and Protocols (Methods in Molecular Biology #2871)
by Wolfgang LinkThis second edition volume expands on the previous edition with updates on the latest techniques and technologies used in FOXO research. The chapters in this book are organized into five parts. Part One covers biochemical techniques used to analyze phosphorylation status of FOXO proteins, identify FOXO binding partners, and assess FOXO-specific transcriptional activity. Part Two highlights genetic techniques that are used to identify functional domains and validate disease relevance. Part Three talks about biophysical and bioinformatic methods to study the structure and dynamics of FOXO proteins, and protein-protein interactions. Part Four discusses different fluorescence and imaging techniques to measure FOXO translocation, and Part Five focuses on functional studies in model organisms to characterize cell death regulation and life- and healthspan. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Comprehensive and cutting-edge, FOXO Transcription Factors: Methods and Protocols, Second Edition is a valuable resource for both expert and novel researchers who want to learn more about this exciting and developing field of FOXO biology.
FRCR Physics MCQs in Clinical Radiology
by Ibrahim Lutfi Shuaib Hafiz M. Zin Mohd Zahri Aziz Noor Diyana Osman Rafidah ZainonThis book offers a collection of specimen multiple choice questions (MCQs) for the first FRCR examination in clinical radiology that is for the physics module. It includes questions arranged in nine sets of 40 MCQs following the examination format. Additionally, chapters cover explanation to some of the answers for better understanding of the topics. The book covers updated syllabus of Royal College of Radiology (RCR), UK on scientific basis of medical imaging, including topics in molecular imaging. Each chapter with a practice set comprises of questions arranged in the order of the syllabus of the examination, starting from the basis of medical imaging and radiation physics to the principles of specific modalities and safety issues. This book offers assistance to candidates preparing for the first FRCR examination, clinical radiology trainees, and radiology and nuclear medicine postgraduate students.
FREIGHTVISION - Sustainable European Freight Transport 2050
by Stephan Helmreich Hartmut KellerThis book has been written on the basis of the research done between 2008 and 2010 as part of the European Commission funded FREIGHTVISION project. The "FREIGHTVISION - Freight Transport 2050 Foresight" project was funded by the Directorate General MOVE to design a long term vision for European freight transport in 2050 and to identify actions and research to progress appropriate freight transport measures in Europe. The project was carried out as a foresight process encompassing four conferences in which the project team identified and developed with the aid of more than 100 experts an action plan for securing long term freight transport in Europe. The book provides insights into the freight transport visions and Backcasts identified for 2035 and 2050, issues which need to be addressed and measures which were assessed to be part of future paths to assure an economical, environmental, and social freight transport system.
FRET - Förster Resonance Energy Transfer
by Niko Hildebrandt Igor MedintzMeeting the need for an up-to-date and detailed primer on all aspects of the topic, this ready reference reflects the incredible expansion in the application of FRET and its derivative techniques over the past decade, especially in the biological sciences. This wide diversity is equally mirrored in the range of expert contributors.The book itself is clearly subdivided into four major sections. The first provides some background, theory, and key concepts, while the second section focuses on some common FRET techniques and applications, such as in vitro sensing and diagnostics, the determination of protein, peptide and other biological structures, as well as cellular biosensing with genetically encoded fluorescent indicators. The third section looks at recent developments, beginning with the use of fluorescent proteins, followed by a review of FRET usage with semiconductor quantum dots, along with an overview of multistep FRET. The text concludes with a detailed and greatly updated series of supporting tables on FRET pairs and Förster distances, together with some outlook and perspectives on FRET. Written for both the FRET novice and for the seasoned user, this is a must-have resourcefor office and laboratory shelves.