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This book represents a critical appraisal of the major clinical trials that have had a significant impact on clinical research and practice during the last decade. Each trial follows a strict format, starting with reference to the original source of publication, details on the key investigators and their methods of research. The strengths and weaknesses of each trial are discussed as well as their influence on clinical practice. Articles are complemented by a diagrammatic summary of the trial design and the key findings. It is estimated that over 20 million men in Europe alone suffer at some time in their life from erectile dysfunction (ED). This is the first book to bring together in a single volume a critical review of all the major trials in ED. It will be an essential reference for both clinicians and research workers in urology, sexual dysfunction and related disorders.
History of human medicine --- Urology. Andrology --- geneeskunde --- geschiedenis --- urologie
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Mal emblématique, le cancer du sein accompagne l'histoire des femmes. Il déborde infiniment le champ des connaissances et des actions de la médecine. Il renvoie aux questions fondamentales que se pose tout être humain. Mon avenir est-il une page blanche ? Qu'est-ce que la vérité ? La raison peut-elle rendre compte de tout ? Est-ce que les autres m'aiment ? Que peuvent les forces de l'esprit ? Pourquoi ne suis-je pas immortel ? Pour répondre, l'auteur puise dans l'art, la psychologie, l'histoire ou la philosophie et illustre sa réflexion au travers de magnifiques illustrations en couleur. Il offre un plaidoyer pour une médecine du sein plus sereine, une analyse des ambiguïtés de la société face à une maladie devenue insupportable, soulève des interrogations sur des actions sanitaires collectives qui s'inscrivent dans le consumérisme, les enjeux médicaux, économiques et politiques. Comment penser le cancer du sein, ce mal emblématique qui accompagne l'histoire des femmes, des hommes et des sociétés ? Souvent "médicalement incorrect", l'ouvrage est une quête de vérité face à une maladie dépourvue de sens. Cet itinéraire de réflexion s'inspire du quotidien d'un humaniste, médecin de terrain, et philosophe, passionnément ouvert à l'art et à la vie. Dominique Gros, sénologue à Strasbourg, est connu pour ses contributions originales sur le thème de l'art et du cancer.
History of human medicine --- Oncology. Neoplasms --- History --- geneeskunde --- geschiedenis --- oncologie
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Depuis la publication de Josef Plenck (1776) reconnue comme fondatrice de la dermatologie, la compréhension des maladies de la peau et l'évolution de la discipline ont évolué au rythme de mutations conceptuelles et de controverses. Philosophie et botanique, disciplines de réflexion et de classification, eurent un rôle déterminant, fondateur du diagnostic clinique. Quelques décennies plus tard, le microscope, d'abord fortement controversé, trouva en dermatologie un champ d'application privilégié en renforçant l'idée de spécificité de la cause. À la même époque, l'invention de la photographie simplifia le recueil des images de la peau, facilita les échanges et obligea à davantage de rigueur descriptive. Le contexte politique fut à l'origine d'autres mutations essentielles comme, en France, la spécialisation hospitalière et plus tard la spécialisation universitaire en dermatologie. L'orientation résolue des dermatologues américains en faveur de la recherche à la fin des années 1930 s'inscrivit aussi dans une volonté politique d'affirmer l'influence grandissante de cette école nouvelle. La syphilis tint une place de choix dans les évolutions de pensée qui façonnèrent la dermatologie. La mise au point du diagnostic biologique initiateur de la sérologie médicale, les premiers traitements spécifiques qui ouvrirent la voie des chimiothérapies, le succès éclatant de l'antibiothérapie en sont quelques exemples. Ces mutations empruntées à l'environnement intellectuel, social et politique ont amené la dermatologie dans des directions nouvelles, imprévues. Certaines survinrent sur des esprits non entièrement prêts à les accepter, d'autres naquirent de concepts erronés. Toutes furent à l'origine d'avancées et de controverses passionnées qui sont le sujet de cet ouvrage.
History of human medicine --- Pathological dermatology --- geneeskunde --- geschiedenis --- dermatologie
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Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
History of human medicine --- Pharmacology. Therapy --- Neuropathology --- neurologie --- farmacologie --- toxicologie
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Suspension dosage form is a preferred and widely accepted dosage forms for insoluble or poorly soluble drugs for various therapeutic applications. The suspension dosage form has long been used for insoluble and poorly soluble drugs for making oral, topical and parenteral products. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides the reader with a broad overview of suspension drug product technology. Individual chapters in this book focus on suspension formulation principles, excipients, analysis, pharmaceutical development, preclinical, clinical and regulatory aspects, as well as the emerging technology of nanosuspensions as nanomedicine. Various chapters in the book are written by authors from academia, regulatory agencies and industries who are experts in their respective fields. The book includes over 600 bibliographic citations, numerous tables and illustrations. Pharmaceutical Suspensions is the only volume to date that systematically follows the suspension dosage development approach used widely in the pharmaceutical industries starting with pre-formulation/formulation development, pre-clinical evaluation and critical characterization method development, continuing to clinical trial essentials and ending with technology transfer essentials and regulatory filing guidance. Pharmaceutical Suspensions, From Formulation Development to Manufacturing provides a useful resource for pharmaceutical scientists, process scientists/engineers involved in the areas of research and development of pharmaceutical suspension dosage forms as well as for advanced pharmacy undergraduate and graduate students who want in-depth knowledge of suspension dosage form. "Solid useful text on suspension formulation development"
History of human medicine --- Pharmacology. Therapy --- farmacologie --- toxicologie
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The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops - the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
History of human medicine --- Pharmacology. Therapy --- farmacologie --- toxicologie
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This book aims to bring to the forefront a field that has been developing since the late 1990s called the STAR pathway for Signal Transduction and Activation of RNA. It is a signaling pathway that targets RNA directly; in contrast to the canonical signal kinase cascade transcription factor DNA RNA. It is proposed to allow quick responses to environment changes such as those necessary in many biological phenomenona such as the nervous system, and during development. The pathway is diagramed in Chapter 1, Figure1. This chapter is a historical introduction and general review with some new data on theoretical miRNAs binding sites and STAR mRNAs. In Chapter 2, Feng and Banks address the accumulating evidence that the RNA-binding activity and the homeostasis of downstream mRNA targets of STAR proteins can be regulated by phosphorylation in response to various extracellular signals. Then Ryder and Massi review the available information on the structure of the RNA binding STAR domain and provides insights into how these proteins discriminate between different RNA targets. Next Claudio Sette offers an overview of the post-translational modifications of STAR proteins and their effects on biological functions, followed by two chapters dedicated to in depth review of STAR function in spermatogenesis and in mammalian embryonic development. Chapters 7 and 8 discuss what can be learned from STAR proteins in non-mammalian species; in Drosophila and Gld-1 and Asd-2 in C. elegans. Next Rymond discusses the actual mech- ics of splicing with mammalian SF1.
History of human medicine --- Pharmacology. Therapy --- Neuropathology --- neurologie --- farmacologie --- toxicologie
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Baruch A. Brody has been one of the most important voices in bioethics over the last several decades, asking new and challenging questions about a range of problems, examining recalcitrant issues in novel ways, always with the goal of offering practical solutions to complex problems. This volume presents a sustained philosophical analysis of Brody's contributions to biomedical ethics. The essays in this volume compass epistemological, methodological, and topical contributions to bioethics, including both application and criticism of Brody's normative moral theory - pluralistic casuistry - Jewish medical ethics, human embryo transfer, medical futility, life and death decisions in pediatrics, euthanasia and end-of-life decision-making, the obligations of clinical researchers toward study participants, and professional integrity. Done well, philosophical work can clarify complex issues, facilitate creative problem solving, and lead to real-world solutions to difficult situations. Each contributor carefully and critically explores Brody's writings in biomedical ethics and the philosophy of medicine, illustrating his appreciation that thorough and critical scientific research and philosophical analysis are central to reining in the untutored human desire to ameliorate pain and suffering so that medical treatments and health care policy do more good than harm.
Professional ethics. Deontology --- History of human medicine --- filosofie --- geneeskunde --- deontologie
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Regenerative medicine is rich with promethean promises. The use of human embryonic stem cells in research is justified by its advocates in terms of promises to cure a wide range of diseases and disabilities, from Alzheimer's and Parkinsonism to the results of heart attacks and spinal cord injuries. More broadly, there is the promethean allure of being able to redesign human biological nature in terms of the goals and concerns of humans. Needless to say, these allures and promises have provoked a wide range of not just moral but metaphysical reflections that reveal and reflect deep fault-lines in our cultures. The essays in this volume, directly and indirectly, present the points of controversy as they tease out the character of the moral issues that confront any attempt to develop the human regenerative technologies that might move us from a human to a post-human nature. Although one can appreciate the disputes as independently philosophical, they are surely also a function of the conflict between a Christian and a post-Christian culture, in that Christianity has from its beginning recognized a fundamental prohibition against the taking of early human life. Even the philosophical disputes that frame secular bioethics are often motivated and shaped by these background cultural conflicts. These essays display this circumstance in rich ways.
Philosophy --- General ethics --- History of human medicine --- ethiek --- filosofie --- geneeskunde
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Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.
History of human medicine --- Pharmacology. Therapy --- farmacologie --- toxicologie
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