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VG ☆ India, 2012-07-23 09:13 (5088 d 09:19 ago) Posting: # 8968 Views: 4,014 |
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Dear all Can any one let me know is it required for conducting a steady state study for modified release formulations as per the recent EMA guidlines. Regards VG |
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drgunasakaran1 ★★  2012-07-24 07:43 (5087 d 10:49 ago) @ VG Posting: # 8972 Views: 3,617 |
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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. — 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 |
Ing. Helmut Schütz