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The Relevance Of Ethnic Factors In The Clinical Evaluation Of Medicines
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Book Synopsis The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines by : S.R. Walker
Download or read book The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines written by S.R. Walker and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.
Book Synopsis Unequal Treatment by : Institute of Medicine
Download or read book Unequal Treatment written by Institute of Medicine and published by National Academies Press. This book was released on 2009-02-06 with total page 781 pages. Available in PDF, EPUB and Kindle. Book excerpt: Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color.
Book Synopsis Understanding Racial and Ethnic Differences in Health in Late Life by : National Research Council
Download or read book Understanding Racial and Ethnic Differences in Health in Late Life written by National Research Council and published by National Academies Press. This book was released on 2004-09-08 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the population of older Americans grows, it is becoming more racially and ethnically diverse. Differences in health by racial and ethnic status could be increasingly consequential for health policy and programs. Such differences are not simply a matter of education or ability to pay for health care. For instance, Asian Americans and Hispanics appear to be in better health, on a number of indicators, than White Americans, despite, on average, lower socioeconomic status. The reasons are complex, including possible roles for such factors as selective migration, risk behaviors, exposure to various stressors, patient attitudes, and geographic variation in health care. This volume, produced by a multidisciplinary panel, considers such possible explanations for racial and ethnic health differentials within an integrated framework. It provides a concise summary of available research and lays out a research agenda to address the many uncertainties in current knowledge. It recommends, for instance, looking at health differentials across the life course and deciphering the links between factors presumably producing differentials and biopsychosocial mechanisms that lead to impaired health.
Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309443571 Total Pages :85 pages Book Rating :4.3/5 (94 download)
Book Synopsis Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials by : National Academies of Sciences, Engineering, and Medicine
Download or read book Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-09-24 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis General Considerations for the Clinical Evaluation of Drugs by : United States. Food and Drug Administration. Bureau of Drugs
Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Responsibility for Drug-induced Injury by : Graham Dukes
Download or read book Responsibility for Drug-induced Injury written by Graham Dukes and published by IOS Press. This book was released on 1998 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edition reflects the evolution of legal standards, professional rules, industrial codes of ethics, and court experience in cases involving recompense for medical injury since the 1988 version. While deriving from legal standards of the US, British Commonwealth, European Union, and Nordic Council, a chapter is devoted to issues particular to developing countries. Following an introductory chapter on the emergence and recognition of problems relating to drug safety, 20 chapters cover such areas as: the legal framework (types of proceedings, evidence, and proof); the responsibility of everyone from the government and manufacturer to the prescriber and patient; clinical investigation of drugs; controlled drugs; self-medication; alternative and complementary medicine; and vaccines and biologicals. Includes a table of cases, and table of conventions, statutes, and regulations. Annotation copyrighted by Book News, Inc., Portland, OR
Book Synopsis The Medical Model in Mental Health by : Ahmed Samei Huda
Download or read book The Medical Model in Mental Health written by Ahmed Samei Huda and published by Oxford University Press. This book was released on 2019-05-16 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many published books that comment on the medical model have been written by doctors, who assume that readers have the same knowledge of medicine, or by those who have attempted to discredit and attack the medical practice. Both types of book have tended to present diagnostic categories in medicine as universally scientifically valid examples of clear-cut diseases easily distinguished from each other and from health; with a fixed prognosis; and with a well-understood aetiology leading to disease-reversing treatments. These are contrasted with psychiatric diagnoses and treatments, which are described as unclear and inadequate in comparison. The Medical Model in Mental Health: An Explanation and Evaluation explores the overlap between the usefulness of diagnostic constructs (which enable prognosis and treatment decisions) and the therapeutic effectiveness of psychiatry compared with general medicine. The book explains the medical model and how it applies in mental health, assuming little knowledge or experience of medicine, and defends psychiatry as a medical practice.
Book Synopsis The Concept of Race in Natural and Social Science by : E. Nathaniel Gates
Download or read book The Concept of Race in Natural and Social Science written by E. Nathaniel Gates and published by Routledge. This book was released on 2014-05-01 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explores the concept of race The term race, which originally denoted genealogical or class identity, has in the comparatively brief span of 300 years taken on an entirely new meaning. In the wake of the Enlightenment it came to be applied to social groups. This ideological transformation coupled with a dogmatic insistence that the groups so designated were natural, and not socially created, gave birth to the modern notion of races as genetically distinct entities. The results of this view were the encoding of race and racial hierarchies in law, literature, and culture. How racial categories facilitate social control The articles in the series demonstrate that the classification of humans according to selected physical characteristics was an arbitrary decision that was not based on valid scientific method. They also examine the impact of colonialism on the propagation of the concept and note that racial categorization is a powerful social force that is often used to promote the interests of dominant social groups. Finally, the collection surveys how laws based on race have been enacted around the world to deny power to minority groups. A multidisciplinary resource This collection of outstanding articles brings multiple perspectives to bear on race theory and draws on a wider ranger of periodicals than even the largest library usually holds. Even if all the articles were available on campus, chances are that a student would have to track them down in several libraries and microfilm collections. Providing, of course, that no journals were reserved for graduate students, out for binding, or simply missing. This convenient set saves students substantial time and effort by making available all the key articles in one reliable source. Authoritative commentary The series editor has put together a balanced selection of the most significant works, accompanied by expert commentary. A general introduction gives important background information and outlines fundamental issues, current scholarship, and scholarly controversies. Introductions to individual volumes put the articles in context and draw attention to germinal ideas and major shifts in the field. After reading the material, even a beginning student will have an excellent grasp of the basics of the subject.
Download or read book Mental Health written by and published by . This book was released on 2001 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Principles and Practice of Pharmaceutical Medicine by : Lionel D. Edwards
Download or read book Principles and Practice of Pharmaceutical Medicine written by Lionel D. Edwards and published by John Wiley & Sons. This book was released on 2007-04-30 with total page 780 pages. Available in PDF, EPUB and Kindle. Book excerpt: The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS
Book Synopsis Ethnicity in Drug Development and Therapeutics by : Edyta J. Frackiewicz
Download or read book Ethnicity in Drug Development and Therapeutics written by Edyta J. Frackiewicz and published by Cambridge University Press. This book was released on 2011-06-16 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book was first published in 2002. It presents an overview of ethnic and racial differences in response to medications and offers insight into the genetic and non-genetic reasons for these differences. The roles of pharmacogenomics and pharmacogenetics in drug development, regulatory aspects of representing minorities in clinical trials, as well as NIH, ICH and FDA guidelines as they pertain to these issues are examined in detail. Finally, various strategies to increase recruitment and retention of minority populations in clinical trials are considered.
Book Synopsis Handbook of Communication in Oncology and Palliative Care by : David Kissane
Download or read book Handbook of Communication in Oncology and Palliative Care written by David Kissane and published by Oxford University Press, USA. This book was released on 2010 with total page 774 pages. Available in PDF, EPUB and Kindle. Book excerpt: Communication is a core skill for medical professionals when treating patients, and cancer and palliative care present some of the most challenging clinical situations. This book provides a comprehensive curriculum to help oncology specialists optimize their communication skills.
Book Synopsis Safety Evaluation of Biotechnologically-derived Pharmaceuticals by : Susan A. Griffiths
Download or read book Safety Evaluation of Biotechnologically-derived Pharmaceuticals written by Susan A. Griffiths and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline `Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.
Book Synopsis The Law and Ethics of the Pharmaceutical Industry by : M.N.G. Dukes
Download or read book The Law and Ethics of the Pharmaceutical Industry written by M.N.G. Dukes and published by Elsevier. This book was released on 2005-11-04 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards
Book Synopsis Stephens' Detection of New Adverse Drug Reactions by : John Talbot
Download or read book Stephens' Detection of New Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2004-11-19 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine
Book Synopsis Atkinson's Principles of Clinical Pharmacology by : Shiew-Mei Huang
Download or read book Atkinson's Principles of Clinical Pharmacology written by Shiew-Mei Huang and published by Academic Press. This book was released on 2021-10-16 with total page 764 pages. Available in PDF, EPUB and Kindle. Book excerpt: Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK
