求翻译：Relevant scientific literature and the properties of related products should be taken into account. If detailed references to published scientific literature are to be used in place of studies conducted by the applicant, this should be supported by an appropriate justification that reviews the design of the studies and any deviations from available guidelines. In addition, the availability of information on the quality of batches of drug substance used in these referenced studies should be discussed.是什么意思？

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