In drug development, it is essential to determine whether the pharmacokinetic parameters of a new drug candidate, for a given dose range, are linear or nonlinear. While it is impossible to establish a complete PK profile for all doses, prediction of drug exposure in a certain dose range can be easily made if the compound possesses the property of dose proportionality(DP). This property is also called dose-independent and is related to linear PK.

In the analysis of dose proportionality, by administering different doses of drugs, testing the plasma drug concentration of the compound in the animal body, and calculating the drug exposure, the relationship between the administered dose of the small molecule drug and the body exposure can be calculated.

Single Ascending Dose Proportionality Study Protocol

Species Mouse, rat, dog, monkey, cat, rabbit, guinea pig
Dosing route P.O., I.V., I.M.; I. P., etc
Groups Multiple groups with different dosages
Dosing frequency Single Ascending Dose Study
Number of animals 3 per group
Time points 5min, 15 min,30 min, 1 hr, 2 hr, 4 hr, 8 hr, 24 hr (other time points can be chosen)
Analysis method LC-MS/MS , standard curve
Data analysis WinNonlin
Turn Around Time 5 working days

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