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You may consider the interval of 3-5 t/12 to collecting times of BE
studies because you need to obtain the elimination phase (kel) to
calculate the AUC. The Tmax could you find in literature (ex: Goodman
For example: drug X : t1/2 = 8h; Tmax = 1 - 2 h
Sampling times: 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8,
10, 12, 16, 24 h (the highest density of points around Tmax value
To the last point of sampling (24, 48 or 72 h) you may consider LOQ
of your analytical method and the ratio AUC0-t/AUC0-inf higher than 80%.
Please, see guidance of FDA, EMEA, Health Canada or ANVISA (Brazil).
holpe this help.
Daniel Rossi de Campos
PharmPK Discussion List Archive Index page
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