FDA Chemistry Project
Author : United States. Food and Drug Administration
Publisher :
Page : 12 pages
File Size : 37,77 MB
Release : 1965
Category : Butter
ISBN :
Author : United States. Food and Drug Administration
Publisher :
Page : 12 pages
File Size : 37,77 MB
Release : 1965
Category : Butter
ISBN :
Author : Francesco L. Gervasio
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 21,66 MB
Release : 2019-04-29
Category : Medical
ISBN : 3527342656
A guide to applying the power of modern simulation tools to better drug design Biomolecular Simulations in Structure-based Drug Discovery offers an up-to-date and comprehensive review of modern simulation tools and their applications in real-life drug discovery, for better and quicker results in structure-based drug design. The authors describe common tools used in the biomolecular simulation of drugs and their targets and offer an analysis of the accuracy of the predictions. They also show how to integrate modeling with other experimental data. Filled with numerous case studies from different therapeutic fields, the book helps professionals to quickly adopt these new methods for their current projects. Experts from the pharmaceutical industry and academic institutions present real-life examples for important target classes such as GPCRs, ion channels and amyloids as well as for common challenges in structure-based drug discovery. Biomolecular Simulations in Structure-based Drug Discovery is an important resource that: -Contains a review of the current generation of biomolecular simulation tools that have the robustness and speed that allows them to be used as routine tools by non-specialists -Includes information on the novel methods and strategies for the modeling of drug-target interactions within the framework of real-life drug discovery and development -Offers numerous illustrative case studies from a wide-range of therapeutic fields -Presents an application-oriented reference that is ideal for those working in the various fields Written for medicinal chemists, professionals in the pharmaceutical industry, and pharmaceutical chemists, Biomolecular Simulations in Structure-based Drug Discovery is a comprehensive resource to modern simulation tools that complement and have the potential to complement or replace laboratory assays for better results in drug design.
Author : United States. Food and Drug Administration. Division of Microbiology
Publisher :
Page : 180 pages
File Size : 41,70 MB
Release : 1969
Category : Microbiology
ISBN :
Author : Otto G. Piringer
Publisher : John Wiley & Sons
Page : 606 pages
File Size : 16,74 MB
Release : 2008-07-11
Category : Science
ISBN : 3527613293
Plastics have developed into the most important class of packaging materials. Their relative impermeability for substances from the surroundings has great influence on the shelf life and the quality of the packed goods. At the same time the interaction between the contents and the various components of the packaging plays a decisive role. This particular book is indispensable in the search for the optimal plastic packaging. It facilitates the estimation of the influence on the goods which come from the surroundings and from the packaging. The authors do not restrict themselves only to the description of the phenomena of diffusion or transport in theory, but they show what they mean for practical applications. Food represents the central theme as main area of application for plastic packaging. It can be considered to be the "model substance" and the findings are to be applied to many other products and systems. The main rules and regulations for food packaging of the European Community and the United States are presented in this book. Furthermore the authors emphasize the testing methods for proving the mass transport and the sensory check of the quality of the products.
Author : Deborah Blum
Publisher : Penguin
Page : 370 pages
File Size : 27,37 MB
Release : 2018-09-25
Category : Political Science
ISBN : 0525560289
A New York Times Notable Book The inspiration for PBS's AMERICAN EXPERIENCE film The Poison Squad. From Pulitzer Prize winner and New York Times-bestselling author Deborah Blum, the dramatic true story of how food was made safe in the United States and the heroes, led by the inimitable Dr. Harvey Washington Wiley, who fought for change By the end of nineteenth century, food was dangerous. Lethal, even. "Milk" might contain formaldehyde, most often used to embalm corpses. Decaying meat was preserved with both salicylic acid, a pharmaceutical chemical, and borax, a compound first identified as a cleaning product. This was not by accident; food manufacturers had rushed to embrace the rise of industrial chemistry, and were knowingly selling harmful products. Unchecked by government regulation, basic safety, or even labelling requirements, they put profit before the health of their customers. By some estimates, in New York City alone, thousands of children were killed by "embalmed milk" every year. Citizens--activists, journalists, scientists, and women's groups--began agitating for change. But even as protective measures were enacted in Europe, American corporations blocked even modest regulations. Then, in 1883, Dr. Harvey Washington Wiley, a chemistry professor from Purdue University, was named chief chemist of the agriculture department, and the agency began methodically investigating food and drink fraud, even conducting shocking human tests on groups of young men who came to be known as, "The Poison Squad." Over the next thirty years, a titanic struggle took place, with the courageous and fascinating Dr. Wiley campaigning indefatigably for food safety and consumer protection. Together with a gallant cast, including the muckraking reporter Upton Sinclair, whose fiction revealed the horrific truth about the Chicago stockyards; Fannie Farmer, then the most famous cookbook author in the country; and Henry J. Heinz, one of the few food producers who actively advocated for pure food, Dr. Wiley changed history. When the landmark 1906 Food and Drug Act was finally passed, it was known across the land, as "Dr. Wiley's Law." Blum brings to life this timeless and hugely satisfying "David and Goliath" tale with righteous verve and style, driving home the moral imperative of confronting corporate greed and government corruption with a bracing clarity, which speaks resoundingly to the enormous social and political challenges we face today.
Author : Food and Drug Administration
Publisher :
Page : 0 pages
File Size : 12,83 MB
Release : 2003
Category : Drugs
ISBN : 9780865879737
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author : Barry Leonard
Publisher : DIANE Publishing
Page : 476 pages
File Size : 48,99 MB
Release : 2011-08
Category : Technology & Engineering
ISBN : 143798746X
This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report.
Author : National Research Council
Publisher : National Academies Press
Page : 589 pages
File Size : 26,1 MB
Release : 2010-11-04
Category : Medical
ISBN : 0309163587
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 118 pages
File Size : 34,48 MB
Release : 2012-04-04
Category : Medical
ISBN : 0309222176
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Author : János Fischer
Publisher : John Wiley & Sons
Page : 258 pages
File Size : 50,98 MB
Release : 2015-05-04
Category : Medical
ISBN : 3527336850
The first volume of the book series "Successful Drug Discovery" is focusing on new drug discoveries during the last decade, from established drugs to recently introduced drugs of all kinds: small-molecule-, peptide-, and protein-based drugs. The role of serendipity is analyzed in some very successful drugs where the research targets of the lead molecule and the drug are different. Phenotypic and target-based drug discovery approaches are discussed from the viewpoint of pioneer drugs and analogues. This volume gives an excellent overview of insulin analogues including a discussion of the properties of rapid-acting and long-acting formulations of this important hormone. The major part of the book is devoted to case histories of new drug discoveries described by their key inventors. Eight case histories range across many therapeutic fields. The goal of this book series is to help the participants of the drug research community with a reference book series and to support teaching in medicinal chemistry with case histories and review articles of new drugs.