Bioequivalence and Bioavailability Forum

Dear roody!

❝ Is there any clinical significance in maintaining the same temperature (Study room/area) while conducting a BA/BE study? or Changes in humidity/temperature affects the bioavailability results in healthy human volunteers?

Yes, ‘climatic conditions’ may influence BA – just think about gastric motility, liver blood flow, etc.

But in a cross-over setting this should not matter, since all treatments will be affected in the same way. You may see a significant period effect in ANOVA, but this does not alter treatment differences.

Anyhow, if you suspect large ‘climatic’ changes in your clinical site, you may simply record temperature and humidity on treatment days. I remember one study, where the local meteorological station was asked for weather recordings of the study days, since there was a period effect observed and a regulatory agency wanted an ‘explanation’ some years after performance of the study.

Only if you want to wear a waistbelt plus braces/suspenders you may opt for airconditioning…