TABLE 2.

Qualification opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use regarding the HFS-TB (48)

The HFS-TB is qualified to be used in anti-TB drug development programs as an additional and complementary tool to existing methodology to inform selection of dose and treatment regimen, to maximize bactericidal effects and minimize emergence of resistance. More specifically, the HFS-TB may be useful as follows: To provide preliminary proof of concept for developing a specific drug or combination to treat tuberculosis To select the pharmacodynamic target (e.g., T/MIC, AUC/MIC) To provide data to support PK/PD analyses leading to initial dose selection for nonclinical and clinical studies, with the aim of limiting the number of regimens that are to be tested in vivo; it is anticipated that HFS-TB may be used to limit doses tested both in single-drug and combination regimen studies in vivo To assist in confirming dose regimens for later clinical trials, taking into account the accumulated human PK data in healthy volunteers and then patients as well as available information on exposure-response relationships