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ioanam ★ Romania, 2009-02-17 20:15 (6335 d 08:45 ago) Posting: # 3264 Views: 5,999 |
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Dear all, I would like to know if for omeprazole delayed release capsules (10 mg, 20 mg and 40 mg strengths) which of the following design is appropriate: - single dose 40 mg fast, single dose 40 mg fed and multiple dose 40 mg (fast), associated with a biowaiver for 10, 20 and 40 mg. or - single dose fast 20 mg; single dose fed 20 mg; multiple dose 20 mg and multiple dose 40 mg associated with biowaiver for 10 and 20 mg. I did not found certain information on linearity from 20 to 40 mg. Thank you. |
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Helmut ★★★ ![]() Vienna, Austria, 2009-02-17 20:28 (6335 d 08:32 ago) @ ioanam Posting: # 3265 Views: 5,231 |
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Dear Jo, for which country/regulation? FDA requires four studies:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ioanam ★ Romania, 2009-02-17 20:39 (6335 d 08:21 ago) @ Helmut Posting: # 3267 Views: 6,124 |
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For EU. |
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Helmut ★★★ ![]() Vienna, Austria, 2009-03-06 18:03 (6318 d 10:57 ago) @ ioanam Posting: # 3334 Views: 5,035 |
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— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Prashanth ☆ 2009-02-19 14:22 (6333 d 14:39 ago) @ Helmut Posting: # 3277 Views: 5,074 |
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Dear Helmut, With respect to comments given to Jo, i would like to know 40mg single dose, sprinkle, Kindly let me know what is sprinkle — Best Regards, Prashanth |
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Helmut ★★★ ![]() Vienna, Austria, 2009-02-19 15:07 (6333 d 13:54 ago) @ Prashanth Posting: # 3278 Views: 5,181 |
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— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Prashanth ☆ 2009-02-19 20:42 (6333 d 08:19 ago) @ Helmut Posting: # 3279 Views: 5,290 |
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Dear Helmut, Thanks for updating me..... — Best Regards, Prashanth |

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