Bioequivalence and Bioavailability Forum

USP dissolution test 2:
two-point dissolution specification, one at 15 min. and and the other at a later point

"Between 45% and 75% of the labeled amount is dissolved in 15 min" is a claim regarding the safety of the Carbamazepine 200mg, immediate release tablets?

More than 75% carbamazepine dissolved at 15 min. would represent a warning on the rate of potential absorption?

Is the 2-point dissolution requirement correlated with formulations considered to be Narrow Therapeutic Index Drugs?

Thank you

Irina

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070237.pdf