Our preliminary results showed that the psychometric properties (acceptability and reliability) of the Spanish SSQOL questionnaire are good, encouraging, and comparable to those of other similar studies. This study is the first approach to validate the Spanish version of the SSQOL questionnaire in Mexican stroke survivors.
The completeness of the information provided in the suspected ADR reports submitted during the sample study years was incomplete and, in general, did not fulfil the requirements established by the NOM guidelines. Among the pharmaceutical industry, CEFV and CIFV, the suspected ADR reports were mainly provided by the pharmaceutical industry. It is necessary to improve the pharmacovigilance system in Mexico to achieve a high level of completeness of suspected ADR reports that totally fulfil the standing regulations.
The completeness of the information provided in the suspected ADR reports submitted during the sample study years was incomplete and, in general, did not fulfil the requirements established by the NOM guidelines. Among the pharmaceutical industry, CEFV and CIFV, the suspected ADR reports were mainly provided by the pharmaceutical industry. It is necessary to improve the pharmacovigilance system in Mexico to achieve a high level of completeness of suspected ADR reports that totally fulfil the standing regulations.
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