Pharmacokinetics methods |
Good for comparison of |
Need to differentiate |
relative lung deposition |
between the swallowed |
relative systemic delivery |
and inhaled doses |
Identifies the effective lung |
Does not identify dose deposition into different zones of the lungs |
Original product used |
Some assays do not have the sensitivity to measure the low concentrations |
Simple crossover design for studies. |
No washout period (can substitute another drug for continued management) |
Can use urine samples |
Shows a dose response relationship |
Gamma scintigraphy |
Widely used – good for comparisons |
Reformulation of the product |
Identifies the total lung dose |
Long-term safety of radionuclide |
Differentiates between deposition |
In vitro validation of |
into different zones of the lungs |
reformulated product required and methods are not standardized |
Striking visual images |
Correction for tissue attenuation |
Simple crossover design |
Tissue attenuation |
No wash-out period required |
Does not identify systemic delivery |
Demonstrates dose-response |
Does not identify the |
relationships |
effective lung dose |
|
Expensive study to commission |