"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--
Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Emerging Technologies for Health Literacy and Medical Practice unveils a transformative revolution brought about by emerging technologies, setting the stage for a paradigmatic shift from reactive medical interventions to proactive preventive measures. This transition has not only redefined the doctor-patient relationship but has also placed patients at the helm of their health management, actively engaged in informed decision-making. The book, a collective effort by experts across diverse disciplines, stands as an authoritative compendium delving into the profound implications of cutting-edge technologies in healthcare. From the tantalizing realm of artificial intelligence powering diagnostics and treatments to the tangible impact of wearable health devices and telemedicine on accessibility, each chapter delves into the nuanced interplay between technology and medical practice. This book spotlights the capabilities of these technologies, as well as dissecting the ethical, social, and regulatory tapestry they unravel. This book, thoughtfully tailored for a spectrum of stakeholders, epitomizes a synergy between knowledge dissemination and empowerment. From healthcare practitioners seeking to optimize medical practices to policymakers navigating the labyrinth of ethical considerations, from educators enriching health literacy to patients empowered to navigate their health journey, the book unearths its relevance across the healthcare spectrum.
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Developing new approaches and reliable enabling technologies in the healthcare industry is needed to enhance our overall quality of life and lead to a healthier, innovative, and secure society. Further study is required to ensure these current technologies, such as big data analytics and artificial intelligence, are utilized to their utmost potential and are appropriately applied to advance society. Big Data Analytics and Artificial Intelligence in the Healthcare Industry discusses technologies and emerging topics regarding reliable and innovative solutions applied to the healthcare industry and considers various applications, challenges, and issues of big data and artificial intelligence for enhancing our quality of life. Covering a range of topics such as electronic health records, machine learning, and e-health, this reference work is ideal for healthcare professionals, computer scientists, data analysts, researchers, practitioners, scholars, academicians, instructors, and students.
Explainable artificial intelligence is proficient in operating and analyzing the unconstrainted environment in fields like robotic medicine, robotic treatment, and robotic surgery, which rely on computational vision for analyzing complex situations. Explainable artificial intelligence is a well-structured customizable technology that makes it possible to generate promising unbiased outcomes. The model’s adaptability facilitates the management of heterogeneous healthcare data and the visualization of biological structures through virtual reality. Explainable artificial intelligence has newfound applications in the healthcare industry, such as clinical trial matching, continuous healthcare monitoring, probabilistic evolutions, and evidence-based mechanisms. Principles and Methods of Explainable Artificial Intelligence in Healthcare discusses explainable artificial intelligence and its applications in healthcare, providing a broad overview of state-of-the-art approaches for accurate analysis and diagnosis. The book also encompasses computational vision processing techniques that handle complex data like physiological information, electronic healthcare records, and medical imaging data that assist in earlier prediction. Covering topics such as neural networks and disease detection, this reference work is ideal for industry professionals, practitioners, academicians, researchers, scholars, instructors, and students.
