Modafinil Enantiomer Analysis? [Regulatives / Guidelines]
Dear All,
We are planning to conduct bioequivalence study of Modafinil 100 mg tablets for Australia submission. Modafinil is a racemic compound and in SMPC it has been mentioned that “the enantiomers have different pharmacokinetics where the elimination t1/2 of the R-isomer is three times that of the S-isomer in adult humans”. However they are pharmacologically equipotent.
As per applicable guideline, whether we need to establish bioequivalence on each enantiomer or racemic will suffice the regulatory requirement.
We are planning to conduct bioequivalence study of Modafinil 100 mg tablets for Australia submission. Modafinil is a racemic compound and in SMPC it has been mentioned that “the enantiomers have different pharmacokinetics where the elimination t1/2 of the R-isomer is three times that of the S-isomer in adult humans”. However they are pharmacologically equipotent.
As per applicable guideline, whether we need to establish bioequivalence on each enantiomer or racemic will suffice the regulatory requirement.
Complete thread:
- Modafinil Enantiomer Analysis?hari emmadi 2016-08-22 06:30 [Regulatives / Guidelines]