In addition, two participants in the leflunomide group reported inability to comply with the cholestyramine washout as prescribed due to unpleasant taste and consistency and frequency of dosing.
Recent regulatory guidelines, among which the U.S.FDA draft guidance is the most stringent, demand consistent dose delivery from an inhaler throughout its life and consistency of doses from one inhaler to another.
No statistical analysis was planned, as it was considered unlikely that there would be sufficient consistency of drug used, dose, titration regimen, duration, or comparator that would provide sufficient information for any sensible comparator.
The results of calculation and measurements have revealed good consistency of gamma dose and fast neutron 2D distributions obtained with gel dosimeters in form of layers.
To evaluate differences between three new-generation nebulizers Pari LC Star (Pari Respiratory Equipment; Mississauga, ON, Canada), AeroEclipse (Trudell Medical International, London, ON, Canada), and Halolite (Medic-Aid Limited, West Sussex, UK in terms of rate and amount of expected deposition as well as the consistency of the doses delivered.
This approach enables assessing the consistency of the dose-response relationship.
The consistency of toxic doses across species when normalised to body surface area reflects the general relationship between surface area and a number of physiological processes which together determine drug clearance, as alluded to above.
This is evidenced by the oxygen debt/probability of death curves for the animals, and by the consistency of lethal dose (LD 25,50 points for base deficit across all three species.
The authors concluded, "From a weight-of-evidence point of view, the hypothesized mode of action for formaldehyde-induced nasal tumors satisfies several criteria, including consistency, concordance of dose-response relationships across all key events, and biological plausibility and coherence of the database.
Examining the consistency of the allele doses inferred between the parents and progeny may be helpful, as long as the alleles have similar amplification efficiencies.
