Bioequivalence and Bioavailability Forum

❝ Dear All,

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❝ As per Guidelines for Bioavailability and Bioequivalence Studies issued by CDSCO-India, intervals between sampling time points used to calculate the terminal elimination rate constant should not be longer than the half life of the study drug. Any reason behind this??

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❝ Regards,

❝ Naren

Hi Naren its a very good question, i think its linked with guidelines recommendation (im speaking by memory) in my opinion its necessary 3 half-lives to calculate the overall pk sampling time because you want to include at least 80% of the AUC, but again, i have to look it in the guidelines (one more task for this friday)

Maybe some seniors members can add some experience in this matter

best regards

Javier