Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Download or read book Medical Product Safety Evaluation written by Jie Chen and published by CRC Press. This book was released on 2018-09-03 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.
Download or read book Control Systems Safety Evaluation and Reliability written by William M. Goble and published by . This book was released on 1998 with total page 515 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Preclinical Safety Evaluation of Biopharmaceuticals written by Joy A. Cavagnaro and published by John Wiley & Sons. This book was released on 2013-03-07 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
Download or read book Evaluation of Fire Safety written by D. Rasbash and published by John Wiley & Sons. This book was released on 2004-04-21 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fire safety is a major concern in many industries, particularly as there have been significant increases in recent years in the quantities of hazardous materials in process, storage or transport. Plants are becoming larger and are often situated in or close to densely populated areas, and the hazards are continually highlighted with incidents such as the fires and explosions at the Piper Alpha oil and gas platform, and the Enschede firework factory. As a result, greater attention than ever before is now being given to the evaluation and control of these hazards. In a comprehensive treatment of the subject unavailable elsewhere, this book describes in detail the applications of hazard and risk analysis to fire safety, going on to develop and apply quantification methods. It also gives an explanation in quantitative terms of improvements in fire safety in association with the costs that are expended in their achievement. Furthermore, a quantitative approach is applied to major fire and explosion disasters to demonstrate crucial faults and events. Featuring: Full international coverage and a review of several major fires and explosion disasters. Presentation of the properties and science of fire including the latest research. Detailed coverage of the performance of fire safety measures. This is an essential book for practitioners in fire safety engineering, loss prevention professionals, technical personnel in insurance companies as well as academics involved in fire science and postgraduate students. This book is also a useful reference for fire safety officers, building designers, engineers in the process industries, safety practitioners and risk assessment consultants.
Download or read book Control Systems Safety Evaluation and Reliability written by William M. Goble and published by ISA. This book was released on 2010 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve a wide variety of users. This updated third edition provides the detailed background necessary to understand how to meet important new safety regulations and reliability engineering topics. Professional control system designers will learn to properly evaluate control system components, various system architectures, how to better communicate with vendors, and how to increase accuracy of life-cycle cost estimates. The book is also an excellent text for college courses due to its detailed explanations, practical presentation, and discussion of the difference between theory and real-world application. It provides a basic foundation of material, including probability, statistics, reliability theory definitions, and basic reliability modeling techniques, as well as advanced topics relevant to safety instrumented and control systems. Each chapter contains exercises to assist the reader in applying the theories presented with their practical implementation.
Download or read book Medical Product Safety Evaluation written by Jie Chen and published by CRC Press. This book was released on 2018-09-03 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.
Download or read book Guidelines for Hazard Evaluation Procedures with Worked Examples written by CCPS (Center for Chemical Process Safety) and published by Wiley-AIChE. This book was released on 1992-04-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The newest edition of this fundamental work keeps process engineers up-to-date on the effective methodologies that process safety demands. Almost 200 pages of worked examples are included so that the techniques in the Guidelines can be viewed in easy-to-understand applications. References for further reading, along with charts and diagrams that reflect the latest views and information, make this a completely accessible work. Long used as a training aid, the revised edition of this classic book, with its worked examples, has been made even more effective for educational applications.
Download or read book Occupational Health and Safety in the Care and Use of Nonhuman Primates written by National Research Council and published by National Academies Press. This book was released on 2003-06-13 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a flexible and comprehensive Occupational Health and Safety Program (OHSP) that can identify and mitigate potential hazards. Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs.
Download or read book Safety Evaluation Based on Identification Approaches Related to Time Variant and Nonlinear Structures written by Hans G. Natke and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety evaluation by definition involves many complex factors and thus covers a wide range of topics. In order to focus the content of the workshop the subject matter was specific to the state of the art and the recent developments in nonlinear and time-variant methods employing identification procedures. Participants in the workshop represented a wide range of expertise. They were se lected in order to cover the state of the art of knowledge in fault-detection and dam age assessment, system identification, signal processing, mathematical and physical modelling and applications of techniques such as fuzzy logic and neural networks. The emphasis was placed on the exploitation and understanding of nonlinearity arising from structural or material faults. Figure 1 indicates the range of topics covered in the workshop. Since no unique or general approach yet exists for treating nonlinearity in the field of safety evaluation, many of the topics presented were problem specific. In order to assist the reader in selecting the material of primary interest a matrix of the topics covered by each participant is shown in Table 1. This table relates the authors to the subject matter, providing a guide through the diverse range of topics presented at the workshop.
Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Download or read book Safety and Security Review for the Process Industries written by Dennis P. Nolan and published by Gulf Professional Publishing. This book was released on 2014-09-04 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dennis Nolan, drawing on decades of experience as a well-known safety author and senior loss prevention specialist at Saudi Aramco, provides the essential procedures and checklists in Safety and Security Review for the Process Industries. In addition to guiding the reader through the selection and execution of efficient and complete hazard analysis and safety reviews (such as HAZOP, PHA, What-If, SVA, LOPA, Bowtie), Nolan shares his personal experience and illustrates procedures with real-world examples. Updated throughout to reflect changing practices, the fourth edition expands its scope to include maintenance, exploratory drilling, and governmental regulation updates. It adds best practice guidelines on CHAZOP reviews, expands on threats in the security vulnerability analysis, and includes more information on chemical process facilities and hydrocarbon/chemical plant safeguards. Up-to-date form templates and "what-if” checklists are also available for purchasers of the book to download, making this a complete safety review toolkit.
Download or read book Safety Assessment for Chemical Processes written by Jörg Steinbach and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of the good safety records of chemical plants many people regard chemical production as dangerous because of a few major accidents that have occurred. A knowledge of at least the fundamentals of chemical safety technology is indispensable for chemists and engineers working in chemical industry. The increasingly stringent legal and administrative requirements can only be answered by more highly qualified employees. This book combines the author's experience of 15 years of research in the field of chemical safety and 10 years in the chemical industry. It provides newcomers with an easy access to the field and helps practitioners in the chemical industry to answer all questions concerning their daily work with hazardous materials or potentially dangerous chemical plants. The investigation of risks, and preventive measures to be taken to minimize the probability of an accident, as well as its consequences are explained.
Download or read book Planning and Evaluation for Public Safety Leaders written by Shane Nordyke and published by Routledge. This book was released on 2021-05-31 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Planning and Evaluation for Public Safety Leaders presents field-tested techniques and tips to help public safety leaders effectively manage their organizations and overcome challenges. Organizations and agencies operating within the public safety sector are unique in many respects. These unique elements provide a different context in which planning, and performance measurement occur. Without recognizing this particular context, most public planning texts ignore crucial pieces of the puzzle when it comes to effectively achieving and measuring public safety outcomes. This book’s practical approach equips students with approachable explanations specific to the public safety context, and practical tools for public safety leaders that can apply to their organizations. Key Features • Each chapter begins with a real-world case from the public safety sector that highlights the importance or possible application of the information covered. • Cases are written in close coordination with the public safety practitioners to illustrate how the concepts covered in the chapter work in a real-world public safety context. • "Put it into Practice" Reflections at the end of each chapter allow new or future public safety leaders to apply the material directly to their current organization. • Boxes describe how to use and apply specific methods in a concise and easy to find tools addressing planning and evaluation challenges as they arise • Key terms and application questions written specifically for students, focus in on the most important concepts and terms from the text. • Overviews of relevant theoretical and scholarly work on the concepts offer connections with course material.
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Download or read book Thermal Safety of Chemical Processes written by Francis Stoessel and published by John Wiley & Sons. This book was released on 2021-05-24 with total page 581 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vollständig überarbeitete,aktualisierte 2. Auflage mit fünf neuen Kapiteln und den aktuellen IUPAC-Normen. Beschäftigt sich mit thermischen Risiken in der chemischen Prozessindustrie. Jedes Kapitel beginnt mit einer Fallstudie und den aus Zwischenfällen gewonnen Erkenntnissen.
Download or read book Traffic Safety Evaluation Research Review written by and published by . This book was released on 1984 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
