As for all other aspects of non-clinical toxicity and safety studies, all the clinical
pathology analyses must be shown to be scientifically valid and must meet GLP
standards. These GLP regulations cover aspects of personnel and management including
training, general laboratory facilities, calibration and maintenance of equipment,
performance of reagents and therefore assays, and characterization of other experimental
variables. Great emphasis is placed on adequate documentation, a clear identification of
‘raw data’ and detailed description of any amendments made to the original results.
As for all other aspects of non-clinical toxicity and safety studies, all the clinicalpathology analyses must be shown to be scientifically valid and must meet GLPstandards. These GLP regulations cover aspects of personnel and management includingtraining, general laboratory facilities, calibration and maintenance of equipment,performance of reagents and therefore assays, and characterization of other experimentalvariables. Great emphasis is placed on adequate documentation, a clear identification of‘raw data’ and detailed description of any amendments made to the original results.
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