Bioequivalence and Bioavailability Forum

Hi Mahesh M,

❝ With regards of USFDA submission for orally inhaled products charcoal block study is required?

FDA are not too hot on charcoal. One reason may be that charcoal block effectiveness has mainly been proven for drugs that are not of much interest to the generic industry now. CC block would be a surrogate for lung deposition, and here you will see that FDA tend to ask for PD instead which is a more direct measure of something relevant.

❝ Is any product specific guidance is available for the same?

None that I know of.

Be careful with this stuff. Many, many companies have failed very painfully under the assumption that in vitro data are indicative of the comparative in vivo performance.