Medical Terminology Help, Please!

[Guest guest]

I found this on TOBI at the FDA site...what is " MIC " ?

Thanks!

Kay W.

FOOD AND DRUG ADMINISTRATION

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ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE

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62ND MEETING

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FRIDAY,

NOVEMBER 21, 1997

First, does treatment with TOBI change the tobramycin susceptibility of P.

aeruginosa? Yes. As might be expected with antibiotic therapy, a small

percentage of patients with TOBI had organisms with increased MICs. However, 85

percent of patients receiving TOBI had organisms of unchanged or decreased MICs

over the six-month study.

Second, is there an MIC value above which no clinical response to TOBI occurs?

No. With the current data, we did not find an MIC value above which no clinical

response to TOBI occurs. It is clear that the tobramycin parenteral break point

of 16 micrograms per ml does not apply to TOBI therapy.

And, last, does treatment with TOBI change the sputum microbial flora? No.

Treatment with TOBI does not appear to cause clinically important changes to

sputum microbial flora. The risk of superinfection with Burkholderia cepacia,

Stenotrophomonas maltophilia, Alcaligenes xylosoxidans was not increased. Fungal

isolation was increased. However, there was no apparent clinical significance to

this finding