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drplacebo ☆ 2007-06-27 08:04 (6944 d 01:59 ago) Posting: # 836 Views: 4,638 |
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Dear HS We are planning for a dossier submission of a FDC to europe. It has three strengths - 80+12.5, 160+12.5 & 160+25. In this If I plan a study on 160+25, can I get a waiver for the other two strengths. All these strengths have qualitatively same composition and dose-weight proportionate, except the 160+12.5, where it is not. Should I do an additional study on this strength? |
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Ohlbe ★★★ France, 2007-06-28 00:45 (6943 d 09:18 ago) @ drplacebo Posting: # 842 Views: 3,634 |
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Dear drplacebo, Proportionality of the formulation is only one of the criteria listed in section 5.4 of the EU Note for Guidance. Please also note that depending on the (non-)linearity of the PK of the two active substances you may have to conduct your trial using the 80 + 12.5 formulation and not on the 160 + 25 formulation (see section 9 of the Q&A document for additional detail). Unless you meet the "5 % rule" in bullet 4 of section 5.4 of the Note for Guidance, you will have to perform also a trial on the 160 + 12.5 formulation. Regards Ohlbe |
Ing. Helmut Schütz