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2.2.1 Introduction
ОглавлениеThe introduction, Section 1 of the guideline, provides an overview of the relationship between the guideline and the closely related quality guidelines, ICH Q3A [5] and Q3B [6]. It also makes clear that the focus of the guideline is on DNA reactive, mutagenic impurities, emphasizing for the first time the specific focus on such impurities as opposed to the more general group of genotoxic impurities. This is a point returned to in more detail in the general principles section.
