Paliperidone product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of paliperidone.

Keywords: Bioequivalence, generics, paliperidone

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current effective version

Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance (Rev. 1)

AdoptedLegal effective date: 01/12/2018Reference Number: EMA/CHMP/156358/2016/Rev. 1Summary:

Revision 1 of the paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance.

Document history

Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance (Rev. 1)

AdoptedLegal effective date: 01/12/2018Reference Number: EMA/CHMP/156358/2016/Rev. 1Summary:

Revision 1 of the paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance.

Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance

AdoptedLegal effective date: 01/07/2017Reference Number: EMA/CHMP/156358/2016Summary:

Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance.

Draft paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance

Consultation dates: 02/05/2016 to 31/07/2016Draft: consultation closedReference Number: EMA/CHMP/156358/2016Summary:

Draft paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance.