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velupharm ☆ 2006-09-04 08:43 (7224 d 08:52 ago) Posting: # 244 Views: 8,050 |
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Dear group we did a pilot study for a drug whose t1/2 of the innovator is 16-25hrs.but in our pilot study we got a t1/2 of 63-70 hrs for both test and reference formulations.so, now when calculating sampling points and washout period for Pivotal study,which data should we consider?-pilot's or original from package insert? |
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Helmut ★★★   Vienna, Austria, 2006-09-07 14:08 (7221 d 03:28 ago) @ velupharm Posting: # 246 Views: 6,511 |
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Dear velupharm, such a case sometimes occurs if your analytical method is improved over the one used by the innovator. Since you will use your—obviously better—method you must also plan your study for the longer half live (otherwise your washout will be far too short). In your case conditions for a long half live drug also apply (truncated AUC, maybe parallel design…). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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velupharm ☆ 2006-09-08 09:33 (7220 d 08:03 ago) @ Helmut Posting: # 248 Views: 6,456 |
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Thank YOU Helmut |
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ghouse1111 ● 2006-12-17 09:30 (7120 d 07:06 ago) @ velupharm Posting: # 404 Views: 6,307 |
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Dear alL, THE WASH OUT PERIODS IN CROSS OVER STUDIES BETWEEN ADMINISTRATION OF TEST AND REFERENCE PRODUCT SHOULD BE USUALLY MORE THAN 5 TIMES THE ELIMINATION HALF LIFE OF PARENT PRODUCT OR ACTIVE METABOLITE. SOME DRUGS LIKE CYCLOSPORIN, & DIGOXIN WILL HAVE MORE GAP BETWEEN PERIOD I AND PERIOD II. GHOUSE1111 |
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Jaime_R ★★ Barcelona, 2006-12-18 01:54 (7119 d 14:42 ago) @ ghouse1111 Posting: # 406 Views: 6,251 |
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Dear ghouse1111, is your Shift-Key jammed?  — Regards, Jaime |
Ing. Helmut Schütz