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Search for biomedical literature citations. Embase is a key resource for conducting systematic reviews and researching evidence-based medicine. Includes specialized pharmacovigilance, drug/disease, and medical device search interfaces.
Indexes journals, including many not in Medline, from over 90 countries, and indexes conference abstracts from many conferences. Broad biomedical scope with strong coverage in drug, pharmaceutical, and toxicological research including economic evaluation.
Search biomedical literature citations from MEDLINE, life science journals, and online books. [1950 - present]
Access to citations from MEDLINE, PreMEDLINE, other journals in the field of medicine and life sciences, and links to NCBI's integrated molecular biology databases including nucleotide sequences, protein sequences, 3-D protein structure data, population study data sets, and assemblies of complete genomes in an integrated system. Note: The link above goes to a specially configured version of PubMed for UC Berkeley users that will display the Get It button for full text access. To use the free public version, please click here.
Comprehensive database for searching across journal articles, conference papers, and online handbooks in all engineering, computer science, and physics disciplines. Includes Compendex, Inspec, and Knovel. [1884-present]
Compendex is the primary literature database for engineering, Inspec is the primary literature database for physics, astronomy, electronics engineering, and computer science, and Knovel is a collection of engineering, chemistry, and physics handbooks.
Search the world's most comprehensive source of references, substances, and reactions in chemistry and related sciences. Note: Restricted to UC Berkeley affiliates. Requires creation of a personal account from an @berkeley.edu email address.
Indexes over 9,000 journals, patents, conferences, books, technical reports and dissertations related to chemistry, chemical engineering, materials science and the biomedical sciences. Relates to the print equivalent Chemical Abstracts. Note: SciFinder-n is the next generation SciFinder platform. You can choose to use either until the old version is phased out, but SciFinder-n includes an updated search algorithm and enhanced features, including synthesis planning
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:
FDA's Advancing Regulatory Science Initiative builds on the achievements of existing Agency programs to transform the way medical products are developed, evaluated, and manufactured. Regulatory Science-Related Agency Activities include:
- Improving Pediatric and Child Care;
- Developing Products for Global Infectious Disease and Bioterrorism;
- Enhancing Safety and Health Through Informatics;
- Meeting the Challenges for Regulating Tobacco;
- Modernizing Toxicology to Advance Public Health.
These reports contain information on new drug application (NDA), biologic license application (BLA), and abbreviated new drug application (ANDA) approvals. The list also includes a link to investigational new drug (IND) activity reports.
A Catalog of FDA approved and tentatively approved prescription, over-the-counter, and discontinued drugs, and Drug approval letters, labels, and review packages. Searchable by drug name, active ingredient, application number, action dates of application approvals and supplements.
Provides information about federally and privately supported clinical research in human volunteers. Information about a trial's purpose, who may participate, locations, and phone numbers for more details.
A repository of both intramural and extramural NIH-funded research projects. Access publications and patents resulting from NIH funding. In addition to NIH-funded research, the system provides access to research supported by CDC, AHRQ, HRSA, SAMHSA, and the VA. Includes the Grants Matchmaker: Enter abstracts or other scientific text and Matchmaker will return lists of similar projects from RePORTER or program officials associated with those projects.
Artificial Intelligence for Drug Development, Precision Medicine, and Healthcare by Mark ChangArtificial Intelligence for Drug Development, Precision Medicine, and Healthcare covers exciting developments at the intersection of computer science and statistics. While much of machine-learning is statistics-based, achievements in deep learning for image and language processing rely on computer science's use of big data. Aimed at those with a statistical background who want to use their strengths in pursuing AI research, the book: · Covers broad AI topics in drug development, precision medicine, and healthcare. · Elaborates on supervised, unsupervised, reinforcement, and evolutionary learning methods. · Introduces the similarity principle and related AI methods for both big and small data problems. · Offers a balance of statistical and algorithm-based approaches to AI. · Provides examples and real-world applications with hands-on R code. · Suggests the path forward for AI in medicine and artificial general intelligence. As well as covering the history of AI and the innovative ideas, methodologies and software implementation of the field, the book offers a comprehensive review of AI applications in medical sciences. In addition, readers will benefit from hands on exercises, with included R code.
Publication Date: 2020
Artificial Intelligence in Medical Imaging: From Theory to Clinical Practice by Lia Morra; Silvia Delsanto; Loredana CorrealeThis book, written by authors with more than a decade of experience in the design and development of artificial intelligence (AI) systems in medical imaging, will guide readers in the understanding of one of the most exciting fields today. After an introductory description of classical machine learning techniques, the fundamentals of deep learning are explained in a simple yet comprehensive manner. The book then proceeds with a historical perspective of how medical AI developed in time, detailing which applications triumphed and which failed, from the era of computer aided detection systems on to the current cutting-edge applications in deep learning today, which are starting to exhibit on-par performance with clinical experts. In the last section, the book offers a view on the complexity of the validation of artificial intelligence applications for commercial use, describing the recently introduced concept of software as a medical device, as well as good practices and relevant considerations for training and testing machine learning systems for medical use. Open problematics on the validation for public use of systems which by nature continuously evolve through new data is also explored. The book will be of interest to graduate students in medical physics, biomedical engineering and computer science, in addition to researchers and medical professionals operating in the medical imaging domain, who wish to better understand these technologies and the future of the field. Features: An accessible yet detailed overview of the field Explores a hot and growing topic Provides an interdisciplinary perspective
Publication Date: 2020
Biomarkers, Diagnostics and Precision Medicine in the Drug Industry critical challenges, limitations and roadmaps for the best practices by Abdel HalimThe high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations
Publication Date: 2019
Bringing Medical Devices to Market by Charlene ChoThe 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.
Publication Date: 2022
Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong (Editor); Raymond Tong (Editor)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.
Publication Date: 2018
ICH Quality Guidelines: an implementation guide by Teasdale; Elder; Nims (Editors)Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. * Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies * Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines * Uses case studies to help readers understand and apply ICH guidelines * Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines * Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Publication Date: 2017
Mass Cytometry: Methods and Protocols by Helen M. McGuire (Editor); Thomas M. Ashhurst (Editor)This book details up-to-date and cutting edge compilation of protocols in mass cytometry. Chapters guide readers through setting up a facility, panel design and reagent preparation, sample preparation, specific applications, and data analysis. 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, Mass Cytometry: Methods and Protocols aims to ensure successful results in the further study of this vital field.
Publication Date: 2019
Medical Device Design: Innovation from concept to market by Peter J. OgrodnikMedical 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
Publication Date: 2020
Medical Device Quality Management Systems: strategy and techniques for improving efficiency and effectiveness by Susanne ManzMedical 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
Publication Date: 2019
An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco by Susan Bain (Editor); Eunjoo Pacifici (Editor)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.
Publication Date: 2018
Pharmacoepidemiology, 6th edition by Brian L. Strom; Stephen E. Kimmel; Sean Hennessy (Editors)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.
Publication Date: 2020
Pharmacoepidemiology and Pharmacovigilance: synergistic tools to better investigate drug safety by Sabrina Nour; Gilles PlourdePharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance
Publication Date: 2019
Pharmacovigilance : a practical approach by Doan, ThaoWritten by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.
Publication Date: 2019
Regulatory Affairs in the Pharmaceutical Industry by Javed Ali; Sanjula Baboota (Editors)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.
Publication Date: 2021
Translational Biotechnology: a journey from laboratory to clinics by Yasha Hasija (Editor)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
Limit to online books if desired by checking the box on the left side of the search results page.
SOPs for Regulatory Applications for the Pharmaceutical Industry
Collection of 11 videos (with PDFs of slides) from The Biomedical & Life Sciences Collection, Henry Stewart Talks on topics such as:
Effective SOP Writing
Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements
Using process mapping, forms and templates for the production of SOPs
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.
Public Health Librarian; Interim Optometry & Vision Science Liaison
Experimental procedures in bioinformatics, cell biology, genetics, molecular biology, neuroscience, toxicology, and other research areas. Click "Journals" at the top of the page to see a full list of titles.
Provides access to Current Protocols in Bioinformatics, Control Protocols in Field Analytical Chemistry, and others in the Current Protocols series.
A repository of shared protocols submitted by researchers. Note: UC students, faculty, and staff have access to premium features such as unlimited private group files, shared notebook records, unlimited storage, and protocol import assistance. For more information about signing up for your free Premium account, please visit this page.
Experimental procedures in biochemistry, bioinformatics, biotechnology, cancer biology, cell biology, genetics/genomics, imaging/radiology, infectious diseases, microbiology, molecular biology and medicine, neuroscience, pharmacology/toxicology, plant sciences, and protein science.
Online versions of Methods in Molecular Biology and Methods in Molecular Medicine. Content includes biochemistry, biotechnology, genetics, microbiology, molecular and cell biology, neuroscience, oncology, and proteomics.
CIOMS is an international, NGO established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, and works on product development, bioethics, and pharmacovigilance,
ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Site includes trainings and standards.
Information on drug discovery, regulatory systems, innovation, and research. Includes codes of conduct, other publications and news, and the Certification Scheme for a
Certificate of Pharmaceutical Product Toolkit.
A stringent regulatory authority (SRA) is a national drug regulation authority which is considered by the World Health Organization to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization.
The PQM program helps low- and middle-income countries strengthen the systems that ensure the quality and increase the supply of priority medicines. Information on strengthening the regulatory systems, increasing supply and quality, and the Medicines Quality Database.
The largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC).