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The GLP regulations aim to standardize procedures and practices in nonclinical studies to ensure accurate, reliable, and traceable data. This background helps highlight the significance of adhering to GLP standards in research and regulatory contexts. GLP was first introduced in New Zealand and Denmark in 1972. [6]
The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, sometimes simply referred to as the animal experimentation convention or laboratory animals convention, [1] is an animal welfare treaty of the Council of Europe regarding animal testing, adopted on 18 March 1986 in Strasbourg, and effective since 1 January 1991.
The National Research Act of 1974 also set up the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced the Belmont Report (Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research) in 1979. This report established a moral framework for the regulation ...
ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
In 1954, the Universities Federation for Animal Welfare (UFAW) decided to sponsor systematic research on the progress of humane techniques in the laboratory. [2] In October of that year, William Russell, described as a brilliant young zoologist who happened to be also a psychologist and a classical scholar, and Rex Burch, a microbiologist, were appointed to inaugurate a systematic study of ...
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation.They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]