Historical Data Analyses and Scientific Knowledge Suggest Complete Removal of the Abnormal Toxicity Test as a Quality Control Test
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چکیده
منابع مشابه
Historical Data Analyses and Scientific Knowledge Suggest Complete Removal of the Abnormal Toxicity Test as a Quality Control Test
In the early 1900s, the abnormal toxicity test (ATT) was developed as an auxiliary means to ensure safe and consistent antiserum production. Today, the ATT is utilized as a quality control (QC) release test according to pharmacopoeial or other regulatory requirements. The study design has not been changed since around 1940. The evidence of abnormal toxicity testing as a prediction for harmful b...
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Sciences
سال: 2014
ISSN: 0022-3549
DOI: 10.1002/jps.24125