Drug discovery guideline recommendations

For some nonclinical studies, primarily drug discovery efforts and pharmacology evaluations conducted in-house by a sponsor, technical reports may not have been prepared but reprints of published journal articles may be available. While this situation is not discussed in the ICH CTD guideline, this author recommends that these publications not be included in place of a technical report. If both a publication and report are available, the technical report should be included since a study report should contain all the data generated during the study while the publication may only summarize these results and might only contain those data that are supportive of the... 

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