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MGR ★ India, 2007-11-26 13:39 (6785 d 13:04 ago) Posting: # 1332 Views: 7,689 |
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Dear all, I had a small doubt regarding the study design. Can we compare two products T and R (both are immediate release products only) but 'T' is a tablet and 'R' is an capsule formulation. Can we do a BE study for this to FDA? Can FDA accept this or not? Thanks in advance. — Regards, MGR |
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H_Rotter ★ Germany, 2007-11-26 15:42 (6785 d 11:01 ago) @ MGR Posting: # 1333 Views: 6,298 |
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Dear MGR! ❝ ... Can we compare two products T and R (both are immediate release products only) but 'T' is a tablet and 'R' is an capsule formulation. Fine according to European regulations - pharmaceutical equivalents or pharmaceutial alternatives may be compared. ❝ Can we do a BE study for this to FDA? Can FDA accept this or not? In the USA only pharmaceutical equivalents (the reference listed drug - RLD) may be used. Best regards, Hermann |
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Noha Abdeljawad ☆ Cairo, Egypt, 2014-08-25 13:20 (4321 d 14:23 ago) @ H_Rotter Posting: # 13426 Views: 5,176 |
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Dear H_Rotter ❝ Fine according to European regulations - pharmaceutical equivalents or pharmaceutical alternatives may be compared. Could you please refer me to the part of the guideline that says that. Thanks — Best Regards Noha Abdeljawad |
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Ohlbe ★★★ France, 2014-08-25 13:57 (4321 d 13:46 ago) @ Noha Abdeljawad Posting: # 13427 Views: 5,162 |
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Dear Noha, ❝ Could you please refer me to the part of the guideline that says that. Have a look not at the BE guideline, but at Directive 2001/83/EC, Article 10, paragraph 2(b), in the definition of a generic medicinal product: ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. [...] The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. — Regards Ohlbe |
Ing. Helmut Schütz