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cher0424 ☆ China, 2014-12-09 02:24 (4220 d 08:52 ago) Posting: # 14026 Views: 6,691 |
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Dear all: I would like to know vital signs checking time design depend on what aspects? Is is have any regulation or lecture have rational context about it? Is it just relate to Cmax and AUC? Thanks advance |
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Helmut ★★★   Vienna, Austria, 2014-12-09 03:22 (4220 d 07:54 ago) @ cher0424 Posting: # 14027 Views: 5,670 |
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Hi cher0424, ❝ […] Is it just relate to Cmax and AUC? Not directly. It depends on the pharmacodynamic (effect) profile. Some IR-formulations have an early tmax and an intermediate t½, but the onset of effect might be ≫tmax and effects last much longer than what you would expect from the PK-profile. No rule is the rule. Check the literature about the drug’s PD. — 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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cher0424 ☆ China, 2014-12-09 04:35 (4220 d 06:42 ago) @ Helmut Posting: # 14028 Views: 5,685 |
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Hi Helmut: Thanks for your prompt reply. And about number of vital signs, also no limit for it? I currently responsible for Pantoprazole Sodium Gastro-Resistant Tablet, the last vital signs check time just two hrs before the last sampling time, and the check-out activities will conduct right after the last sampling. Do you think the time bewteen them is it too close, as we known that check-out activities already include all the vital signs check activities? |
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Helmut ★★★ Vienna, Austria, 2014-12-09 04:50 (4220 d 06:27 ago) @ cher0424 Posting: # 14029 Views: 5,729 |
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Hi cher0424 ❝ I currently responsible for Pantoprazole Sodium Gastro-Resistant Tablet… Pantoprazole is a very safe drug. Cardiovascular side-effects occur only rarely (<1%). I have seen a lot of studies without any scheduled vital signs monitoring… ❝ …the check-out activities will conduct right after the last sampling. That’s OK. — 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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cher0424 ☆ China, 2014-12-09 05:02 (4220 d 06:15 ago) @ Helmut Posting: # 14030 Views: 5,557 |
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Hi Hulmet Thanks a lot! |
Ing. Helmut Schütz