Gerald F. Audette – författare

Pan Stanford Series on NanomedicineDiversity within the broad and evolving arena of nanomedicine and nanopharma is reflected in the expertise of the distinguished contributing authors. The chapters contain key words, figures in full-color and an extensive list of references. As compared to texts on the market, each handbook in the series is comprehensive and intended to be a stand‐alone reference resource, presented in a user-friendly format for easy access. The editors have skillfully curated each chapter to reflect the most relevant and current information possible. The range of topics covered as well as the multidisciplinary approach of the handbooks will attract a global audience. The handbooks are essential reading for both the novice and expert in fields ranging from medicine, biotechnology, pharmaceutical sciences, engineering, FDA law, intellectual property, policy, future studies, ethics, licensing, commercialization, risk analysis, and toxicology.Handbook of Clinical Nanomedicine. Vol. 1. Nanoparticles, Imaging, Therapy, and Clinical Applications, Raj Bawa, PhD, Gerald F. Audette, PhD, and Israel Rubinstein, MD (Editors)This handbook (55 chapters) provides a comprehensive roadmap of basic research in nanomedicine as well as clinical applications. However, unlike other texts in nanomedicine, it not only highlights current advances in diagnostics and therapeutics but also explores related issues like nomenclature, historical developments, regulatory aspects, nanosimilars and 3D nanofabrication. While bridging the gap between basic biomedical research, engineering, medicine and law, the handbook provides a thorough understanding of nano’s potential to address (i) medical problems from both the patient and health provider's perspective, and (ii) current applications and their potential in a healthcare setting.Handbook of Clinical Nanomedicine. Vol. 2. Law, Business, Regulation, Safety, and Risk, Raj Bawa, PhD (Editor), Gerald F. Audette, PhD, and Brian E. Reese, PhD, MBA, JD (Assistant Editors)This unique handbook (60 chapters) examines the entire "product life cycle," from the creation of nanomedical products to their final market introduction. While focusing on critical issues relevant to nanoproduct development and translational activities, it tackles topics such as regulatory science, patent law, FDA law, ethics, personalized medicine, risk analysis, toxicology, nano-characterization and commercialization activities. A separate section provides fascinating perspectives and editorials from leading experts in this complex interdisciplinary field.

This handbook (55 chapters) provides a comprehensive roadmap of basic research in nanomedicine as well as clinical applications. However, unlike other texts in nanomedicine, it not only highlights current advances in diagnostics and therapeutics but also explores related issues like nomenclature, historical developments, regulatory aspects, nanosimilars and 3D nanofabrication. While bridging the gap between basic biomedical research, engineering, medicine and law, the handbook provides a thorough understanding of nano’s potential to address (i) medical problems from both the patient and health provider's perspective, and (ii) current applications and their potential in a healthcare setting.

This unique handbook (60 chapters) examines the entire "product life cycle," from the creation of nanomedical products to their final market introduction. While focusing on critical issues relevant to nanoproduct development and translational activities, it tackles topics such as regulatory science, patent law, FDA law, ethics, personalized medicine, risk analysis, toxicology, nano-characterization and commercialization activities. A separate section provides fascinating perspectives and editorials from leading experts in this complex interdisciplinary field.

The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.

The enormous advances in nanomedicine and precision medicine in the past two decades necessitated this comprehensive reference, which can be relied upon by researchers, clinicians, pharmaceutical scientists, regulators, policymakers, and lawyers alike. This standalone, full-color resource broadly surveys innovative technologies and advances pertaining to nanomedicine and precision medicine. In addition, it addresses often-neglected yet crucial areas such as translational medicine, intellectual property law, ethics, policy, FDA regulatory issues, nano-nomenclature, and artificial nano-machines—all accomplished in a user-friendly, broad yet interconnected format. The book is essential reading for the novice and the expert alike in diverse fields such as medicine, law, pharmacy, genomics, biomedical sciences, ethics, and regulatory science. The book’s multidisciplinary approach will attract a global audience and serve as a valuable reference resource for industry, academia, and government.

The pace and sophistication of advances in medicine in the past two decades have necessitated a growing need for a comprehensive reference that highlights current issues in medicine. Each volume in the Current Issues in Medicine series is a stand‐alone text that provides a broad survey of various critical topics—all accomplished in a user-friendly yet interconnected format. The series not only highlights current advances but also explores related topics such as translational medicine, regulatory science, neglected diseases, global pandemics, patent law, immunotoxicology, theranostics, big data, artificial intelligence, novel imaging tools, combination drug products, and novel therapies. While bridging the gap between basic research and clinical medicine, this series provides a thorough understanding of medicine’s potential to address health problems from both the patient’s and the provider’s perspectives in a healthcare setting. The range of topics covered and the expertise of the contributing authors accurately reflect the rapidly evolving areas within medicine—from basic medical sciences to clinical specialties. Each volume is essential reading for physicians, medical students, nurses, fellows, residents, undergraduate and graduate students, educators, policymakers, and biomedical researchers. The multidisciplinary approach of the series makes it a valuable reference resource for the pharmaceutical industry, academia, and governments. However, unlike other series on medicine or medical textbooks, this series focuses on current trends, perspectives, and issues in medicine that are central to healthcare delivery in the 21st century. Volume 1 focuses on the current issues in basic medical sciences, subjects that are fundamental to the practice of medicine. Specifically, it covers medical biochemistry, genomics, physiology, and pathology. These subjects, traditionally taught in the first two years of medical school that precede clinical instruction, provide a core of basic knowledge critical to the success in clinical medicine during rotations, training, and medical practice.