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Good Clinical Laboratory Practice : ウィキペディア英語版 | Good Clinical Laboratory Practice
Good Clinical Laboratory Practice (GCLP) is a GxP Guideline for laboratory samples from clinical studies. GCP does not define requirements for laboratories and GLP focusses on pre-clinical analyses and not on human samples from clinical trials. The Research Quality Association (RQA) suggested in 2003 a Guideline to close the gap. Later the WHO and the British Health Authority MHRA issued their own versions of a GCLP Guideline. ==Literature==
* 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.
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Good Clinical Laboratory Practice」の詳細全文を読む
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