Bioequivalence and Bioavailability Forum

❝ what is a steady state study? how and when is it done?

Dear drgopal,

The steady state study is made following multiple dose administration. In this case is essential to prove that steady state has been reached. Normally, multiple doses are administered for a period of at least five-times the terminal half-life.

This study is required to sustained-release formulations, drugs with low plasma concentration after a single dose (hormones) and drugs with non-linear pharmacokinetics, considering bioequivalence studies (ANDA). This kind of study is required to new drugs (NDA). Please, for more details see: FDA or EMEA guidances.

Regards,

Daniel