Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food PDF Download

Author:
Publisher:
ISBN:
Category : Coloring matter in food
Languages : en
Pages : 235

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Author: David B. Young
Publisher: Springer Science & Business Media
ISBN: 1468460366
Category : Medical
Languages : en
Pages : 299

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This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.

Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32

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Author:
Publisher:
ISBN:
Category : Food
Languages : en
Pages : 72

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Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32

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Author: National Institutes of Health (U.S.). Division of Biologics Standard
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 40

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Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author: Committee on Clinical Trial Registries
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 128

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To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry. The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.

Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Author: Anand M. Joglekar
Publisher: John Wiley & Sons
ISBN: 0470584122
Category : Science
Languages : en
Pages : 283

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Book Description
HELPS YOU FULLY LEVERAGE STATISTICAL METHODS TO IMPROVE INDUSTRIAL PERFORMANCE Industrial Statistics guides you through ten practical statistical methods that have broad applications in many different industries for enhancing research, product design, process design, validation, manufacturing, and continuous improvement. As you progress through the book, you'll discover some valuable methods that are currently underutilized in industry as well as other methods that are often not used correctly. With twenty-five years of teaching and consulting experience, author Anand Joglekar has helped a diverse group of companies reduce costs, accelerate product development, and improve operations through the effective implementation of statistical methods. Based on his experience working with both clients and students, Dr. Joglekar focuses on real-world problem-solving. For each statistical method, the book: Presents the most important underlying concepts clearly and succinctly Minimizes mathematical details that can be delegated to a computer Illustrates applications with numerous practical examples Offers a "Questions to Ask" section at the end of each chapter to assist you with implementation The last chapter consists of 100 practical questions followed by their answers. If you're already familiar with statistical methods, you may want to take the test first to determine which methods to focus on. By helping readers fully leverage statistical methods to improve industrial performance, this book becomes an ideal reference and self-study guide for scientists, engineers, managers and other technical professionals across a wide range of industries. In addition, its clear explanations and examples make it highly suited as a textbook for undergraduate and graduate courses in statistics.