Laboratory data in healthy volunteers: reference values, reference changes, screening and laboratory adverse event limits in Phase I clinical trialsSibille, M.; Deigat, N.; Durieu, I.; Guillaumont, M.; Morel, D.; Bienvenu, J.; Massignon, D.; Vital Durand, D.
doi: 10.1007/s002280050586pmid: 10206079
Objective: Laboratory data are key evaluation procedures for Phase I clinical pharmacology for two reasons. Firstly, laboratory data are used within the screening process to exclude subjects with asymptomatic diseases, which could result in increased danger to themselves or confuse interpretation of the study results. Secondly, during study implementation, safety evaluation and in particular maximum tolerated dose determination have to be done by a case-by-case analysis, sometimes using laboratory adverse events (LAEs). Thus, relevant limits are needed to discriminate between a usual common variation and a significant abnormality, which is considered to be a LAE. This report presents laboratory data distribution, reference values and reference changes and, based on previously published new methods, suggests inclusion limits at screening and laboratory adverse event limits for analysis during study implementation.
A double-blind study of MPV-2213ad, a novel aromatase inhibitor, in healthy male subjectsAhokoski, O.; Irjala, K.; Huhtala, S.; Salminen, E.; Scheinin, H.; Huupponen, R.
doi: 10.1007/s002280050588pmid: 10206081
Objective: Novel aromatase inhibitors are developed with requirements of high potency and selectivity for the aromatase enzyme. The hormonal effects of a new, non-steroidal competitive inhibitor of the aromatase enzyme, MPV-2213ad, were investigated in this study.