ICH Q12: innovadora y controvertida (parte 2)

Abstract

This work has been published in two parts. In the first, the conceptual framework of the ICH and more specifically of the ICH Q12 was reviewed. In this second, and last, the regulatory and enabling tools of the ICH Q12 are reviewed, which is complemented by a practical part or 'survey' carried out with some professionals in the pharmaceutical industry, although the sample is very small and cannot be generalized, It is important to realize that more information and training on it is necessary at this time for its effective application.