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Tina ★ India, 2013-10-03 18:00 (4646 d 09:01 ago) Posting: # 11601 Views: 3,559 |
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Dear forum, We have developed an oral acqueous solution and there are no approved oral solution in the market. The comparator is a suspension CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** mentions that, ‘If the test product is an aqueous oral solution at time of administration and contains an active substance in the same concentration as an approved oral solution, bioequivalence studies may be waived.’ Considering that approved oral solution isnt available, will biowaiver be a remote possibility? Kind regards, Tina |
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drgunasakaran1 ★★  2013-10-03 21:33 (4646 d 05:28 ago) @ Tina Posting: # 11605 Views: 2,992 |
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Dear Tina, ❝ Considering that approved oral solution isnt available, will biowaiver be a remote possibility? IMHO, obtaining Biowaiver will be a remote possibility since approved oral solution is not available. — 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 |
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ElMaestro ★★★ Denmark, 2013-10-03 22:00 (4646 d 05:02 ago) @ Tina Posting: # 11606 Views: 3,081 |
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Hello Tina, ❝ Considering that approved oral solution isnt available, will biowaiver be a remote possibility? No, it doesn't even sound like a generic to me, cf. article 10.2(b) of 2001/83: "‘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 (...)" Here I am assuming you are aiming for EU since you quoted the EU guideline, but do correct me if this assumption is wrong. So you might need to do a 10.3; then BCS is not so hot. Pre-clinical tests or clinical trials are. The former is only vaguely defined. — Pass or fail! ElMaestro |
Ing. Helmut Schütz