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1.
Modern medical concerns with telemedicine and robotics practiced across national or other jurisdictional boundaries engage the historical, complex area of law called conflict of laws. An initial concern is whether a practitioner licensed only in jurisdiction A who treats a patient in jurisdiction B violates B's laws. Further concerns are whether a practitioner in A who violates a contract or treats a patient in B negligently incurs liability in B, A, or both, and, if treatment lawful in A is unlawful in B, whether the practitioner commits a crime. Judicial procedures are set by courts in which proceedings are initiated, but courts may decline jurisdiction due to inconvenience to parties. If courts accept jurisdiction, they may apply their own substantive legal rules, but may find that the rules of a conflicting jurisdiction should apply. Cross-border care should not change usual medical ethics, for instance on confidentiality, but may mitigate or aggravate migration of specialists. 相似文献
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A test in Internal Medicine of the American National Board of Medical Examiners was given to Swiss medical students as a graduating examination. This study dealing with the feasibility of such an enterprise describes the technical procedures and investigates the problems of translation and the validity of foreign made items. Comparison of item analyses for the 369 Swiss candidates and for a sample of 370 American candidates reveals that most items are of close comparability in difficulty, discrimination and pattern of response to the distractors. In a cross-national comparison of students' responses to the items no systematic content characteristics can be found for items favouring one group or the other. Swiss experts, in judging the validity of the items for testing Swiss students, could indeed identify in advance some of the items that proved to be less valid and more difficult for their—but also the American—students. It is concluded that a National Board examination can be as valid and suited to examine Swiss candidates for licensure as it is to examine American candidates. 相似文献
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《Vaccine》2017,35(33):4064-4071
As companies, countries, and governments consider investments in vaccine production for routine immunization and outbreak response, understanding the complexity and cost drivers associated with vaccine production will help to inform business decisions. Leading multinational corporations have good understanding of the complex manufacturing processes, high technological and R&D barriers to entry, and the costs associated with vaccine production. However, decision makers in developing countries, donors and investors may not be aware of the factors that continue to limit the number of new manufacturers and have caused attrition and consolidation among existing manufacturers. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. In addition, when export is the goal, we describe the requirements to supply those vaccines at affordable prices to low-resource markets, including the process of World Health Organization (WHO) prequalification and supporting policy recommendation. By providing a generalized and consolidated view of these requirements we seek to build awareness in the global community of the benefits and costs associated with vaccine manufacturing and the challenges associated with maintaining consistent supply. We show that while vaccine manufacture may prima facie seem an economic growth opportunity, the complexity and high fixed costs of vaccine manufacturing limit potential profit. Further, for most lower and middle income countries a large majority of the equipment, personnel and consumables will need to be imported for years, further limiting benefits to the local economy. 相似文献
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Boots I Sukhai RN Klein RH Holl RA Wit JM Cohen AF Burggraaf J 《European journal of pediatrics》2007,166(8):849-855
Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated
in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants
patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating
drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All
drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical
pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer.
A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August
2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers,
ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs.
The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the
drug utilization by children.
Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use
the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients,
not by market considerations.
In memory of Isabelle Boots, the primary contributor to this work, who unexpectedly passed away at the brink of a promising
career. 相似文献