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Dear Mr VG,
The Recommendation for Bioequivalence studies for Modififed release formulation in the Recent EMA Guidelines is cross referring to the Modified Release Oral and Transdermal Dosage Forms: Sections I and II (CPMP/QWP/604/96, CPMP/EWP/280/96) Guidances.
Hence, as per the above guidance, "Prolonged release formulations can be assessed as bioequivalent on the basis of single and Multiple Dose Studies". Hence, Steady state study is required for modified release formulation as per recent EMA Guidelines.
The Recommendation for Bioequivalence studies for Modififed release formulation in the Recent EMA Guidelines is cross referring to the Modified Release Oral and Transdermal Dosage Forms: Sections I and II (CPMP/QWP/604/96, CPMP/EWP/280/96) Guidances.
Hence, as per the above guidance, "Prolonged release formulations can be assessed as bioequivalent on the basis of single and Multiple Dose Studies". Hence, Steady state study is required for modified release formulation as per recent EMA Guidelines.
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Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Steady State Study VG 2012-07-23 07:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Steady State Studydrgunasakaran1 2012-07-24 05:43
Ing. Helmut Schütz