English to Spanish Medical Medical: Pharmaceuticals

An overview of the stability batches in on-going stability on xxxxx is shown in Table 1. On-going stability studies are continued up to 36 months (t=36). The stability results for all batches are shown in the CTD documentation. All batches conform to the specification for xxxxx except for an OOS result in the potency assay at time point 18 months for batch 1583. According to standard operating procedures approved during the MA procedure the analytical result is a weighted mean of the results of up to three individual tests.



¿CTD = Documento Técnico Común?

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