Bioequivalence and Bioavailability Forum

Dear all

FDA recently revised the product specific recommendations for Paliperidone palmitate Extended Release Suspension; Intramuscular.


In which, BE study Strength mentioned are 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, 234 mg/1.5 mL


The waiver request of in vivo testing is mentioned as follows,

39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, and 234 mg/1.5 mL (if not studied in vivo) based on (i) acceptable bioequivalence study on the 156 mg/mL strength, (ii) acceptable in vitro dissolution testing of all strengths, and (iii) proportional similarity of the formulations across all strengths.

Based on the above recommendations, i need your opinion on the following,

1) Whether doing BE study on 156mg/mL is a compulsion to get waiver for remaining strengths?

or

2) Is it possible to conduct BE study on any one of the strengths (i.e., 39, 78, 117, 234 mg) to get waiver on remaining strengths?

Request your opinion on the same.

Thanks