Drug Metabolism in Drug Design and Development Basic Concepts and Practice

TABLE 9.2 Example of a CTD table for summarizing

in vivo

metabolism data.

2.6.5.9 Pharmacokinetics:metabolism

in vivo

Test article:

Gender (M/F)/Number of animals:Feeding condition:Vehicle/formulation:Method ofadministration:Dose (mg/kg):Radionuclide:Specific activity:

Species

Sample

Samplingtime orperiod

Percentage

of

dose insample

Percentage

of

compound in

sample

StudyNo.

Locationin CTD

Parent M1 M2

Vol Section

PlasmaUrineBileFecesPlasmaUrineBileFeces

264