Download e-book for iPad: Advancing Regulatory Science for Medical Countermeasure by Institute of Medicine, Board on Health Sciences Policy,

By Institute of Medicine, Board on Health Sciences Policy, Forum on Medical and Public Health Preparedness for Catastrophic Events, Development, and Translation Forum on Drug Discovery, Anne B. Claiborne, Bruce M. Altevogt, Theresa Wizemann

ISBN-10: 0309214904

ISBN-13: 9780309214902

Even if the us has secure and potent scientific countermeasures--such as vaccines, medicinal drugs, and diagnostic tools--available to be used in the course of a catastrophe can suggest the variation among lifestyles and demise for lots of americans. The meals and Drug management (FDA) and the medical neighborhood at huge may benefit from enhanced medical instruments and analytic thoughts to adopt the complicated clinical overview and selection making had to make crucial scientific countermeasures on hand. on the request of FDA, the Institute of medication (IOM) held a workshop to check how you can increase the improvement, review, approval, and rules of scientific countermeasures.

During public healthiness emergencies akin to influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and potent vaccines, remedies, and different clinical countermeasures are necessary to conserving nationwide protection and the health of the general public. Advancing Regulatory technology for scientific Countermeasure Development examines present clinical countermeasures, and investigates the way forward for study and improvement during this sector. Convened on March 29-30, 2011, this workshop pointed out regulatory technology instruments and techniques which are to be had or lower than improvement, in addition to significant gaps in at present on hand regulatory technology instruments.

Advancing Regulatory technology for scientific Countermeasure Development is a priceless source for federal organisations together with the nutrition and Drug management (FDA), the dep. of wellbeing and fitness and Human prone (HHS), the dept of protection (DoD), in addition to overall healthiness execs, and private and non-private wellbeing and fitness organisations.

Show description

Read or Download Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary PDF

Best health policy books

Download e-book for iPad: Fat Politics: The Real Story behind America's Obesity by J. Eric Oliver

It sort of feels virtually day-by-day we learn newspaper articles and watch information reviews exposing the starting to be epidemic of weight problems in the United States. Our govt tells us we're experiencing an enormous overall healthiness quandary, with sixty percentage of american citizens categorized as obese, and one in 4 as overweight. yet how legitimate are those claims?

National Health Insurance in the United States and Canada: by Gerard W. Boychuk PDF

After global conflict II, the us and Canada, nations that have been very related in lots of methods, struck out on substantially divergent paths to public medical insurance. Canada built a common single-payer process of nationwide overall healthiness care, whereas the U.S. opted for a twin procedure that mixes public medical health insurance for low-income and senior citizens with deepest, essentially employer-provided medical insurance - or no coverage - for everybody else.

Read e-book online Occupational and Environmental Health: Recognizing and PDF

Occupational and environmental healthiness is the general public future health and multidisciplinary method of the popularity, prognosis, therapy, prevention, and regulate of illness, accidents, and different opposed medical conditions because of damaging environmental exposures within the place of work, the house, or the group.

Management Engineering for Effective Healthcare Delivery: by Alexander Kolker PDF

As a result of gigantic technological and scientific advances within the existence sciences (molecular genetics, biology, biochemistry, and so on. ), sleek medication is more and more powerful in treating person sufferers, yet little technological development has concerned with advancing the healthcare infrastructure. administration Engineering for powerful Healthcare supply: rules and functions illustrates the ability of administration engineering for quantitative managerial decision-making in healthcare settings.

Additional resources for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary

Example text

Figure 2-1 SOURCE: Susan McCune. 2011. Presentation at IOM workshop; Advancing Regulatory Science for Medical Countermeasure Development. Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary MCM ENTERPRISE AND STAKEHOLDER PERSPECTIVES 17 Center for Biologics Evaluation and Research (CBER) Products regulated by CBER include blood, blood components and derivatives, vaccines, allergenic products, cell and gene therapies, xenotransplantation products, human tissues, and various related devices, explained Carolyn Wilson, associate director for research at CBER.

To aid benefit-risk decisions, Rose suggested, reviewers of MCMs ought to have the requisite security clearances to be allowed to read the associated confidential population threat assessments. In later discussion about safety assessment, Richard Forshee of the Office of Biostatistics and Epidemiology at CBER, mentioned current agency efforts to develop risk assessment models to support regulatory decision making. These probabilistic quantitative computer simulation models can help explore how different regulatory science options could ultimately have an impact on public health, and thereby improve decision making.

Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 30 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT Discovery Use understanding of disease mechanisms to identify and validate targets Toxicology Biomarkers Pharmacogenomics Understand Identify novel Elucidate biological mechanisms behind biomarkers by mechanisms of understanding role differential response drug action and to R(x) in disease pathways toxicity Patient Docetaxel Disease mechanisms Cellular mechanisms Molecular mechanisms Prostate cancer Apoptosis Angiogenesis Fas Vegf Cancer Experimental Data Computational Modeling Literature and Prior Knowledge FIGURE 3-1 In silico modeling of disease mechanisms for drug development.

Download PDF sample

Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary by Institute of Medicine, Board on Health Sciences Policy, Forum on Medical and Public Health Preparedness for Catastrophic Events, Development, and Translation Forum on Drug Discovery, Anne B. Claiborne, Bruce M. Altevogt, Theresa Wizemann


by Paul
4.5

Rated 4.96 of 5 – based on 34 votes