Draft Guideline Use Statistical Signal Detection Methods ...
Data Analysis System integrates statistical methods with traditional methods used in pharmacovigilance. This guideline also recognises that there are specific aspects on the use of quantitative methods for the detection of potential signals …
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Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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