Active Ingredients: Azithromycin
Maine Michigan MI This is demonstrated in Figure 419, which shows in the lower curve changes in alveolar ventilation during a 1-minute period of exercise and in the upper curve changes in arterial Pco 2.
The assays had a lower limit of quantification of 10. In the data analysis, observations that were below the limit of quantification were excluded from the database.
All clearance and distribution parameters are reported as the ratio of the parameter and bioavailability since oral dosing was not accompanied by an intravenous dose. All evaluations used a log-transform both sides approach.
Population PK models were constructed to evaluate the concentration-time data for AZ and CQ and to identify any covariates predictive of PK behaviour using standard approaches.
The structural model consisted of a compartmental PK model to describe the observed concentration-time profiles as well as between subject variability in the PK behaviour. For both AZ and CQ, two- and three-compartment models were evaluated.
In addition, a one-compartment model was also evaluated for completeness, but did not describe the data well and was therefore not used for either drug. The covariate models in this PK model were defined to represent the shift in value of the parameter of interest to a value for a hypothetical patient.
Only those covariates that individually influenced the structural parameters were added to create the full model. The full model then underwent reduction where covariates were removed one at a time and the impact of removal was assessed backward deletion method.
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