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[Japanese guidelines on research use of human materials and disease information].

Demand on the use of human materials and personal disease information for research and development comes on the stage of action. International competition in biomedical and pharmaceutical research pushed the government and related societies about to release guidelines on the issue to ensure the protection of direct and indirect research participants. To work on human materials and information now requires ethical and scientific review by the research ethical committee and the guidelines set the stage of reviewing process. We should aware of the overall view of situation around and of the guidelines before planning the experiments and analyses on human materials and personal information. In this review we summarized the related guidelines and put comments on them to help researchers to understand the situation.

Embryo, Mammalian↗

[Ibn Rushd's treatise on theriac].

Averroes inherited a long tradition about theriac. He examined its nature, quality and utilization as an antidote of poisons or venoms and as a treatment of diseases. He stated that if the electuary, as antidote, was beneficial to the patient and to the physician, it might be dangerous as a regular and repeated medication of disease since it could transform the human nature and render it poison-like. Averroes's purpose was to analyze the advantages and drawback of theriac. He aimed at inducing physicians to more caution. He conducted a medico-philosophical and ethical reflexion on the validity of the medication and he advised against its prophylactic use.

Antidotes↗

Scientific and ethical considerations in trial design for investigational agents for the treatment of human immunodeficiency virus infection.

The design of clinical trials for new antiretroviral agents poses unique challenges, given the availability of highly active antiretroviral therapy (HAART). These challenges include the selection of appropriate populations, the methods used to partition the effects of the study drug under observation from those of the other concurrently administered medications in early studies, performance of dose-ranging studies for disease states in which suboptimal drug exposure may lead to the development of viral resistance that limits future treatment options, and the need to fulfill the obligations of international regulatory agencies. Throughout, science and ethics are tightly woven elements in study designs for antiretroviral drug trials. Fast-track drug approval status and successful lobbying by advocates for patients with acquired immunodeficiency syndrome aimed at the US Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, university teaching centers, pharmaceutical companies, and members of Congress undoubtedly contributed to the development and swift regulatory approvals of the 17 antiretroviral medications now available in the United States for the treatment of human immunodeficiency virus infection.

Anti-HIV Agents↗