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BE-proff ● 2017-04-18 08:25 (2555 d 08:41 ago) Posting: # 17244 Views: 4,227 |
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Hi All, Let's say I have developed a new molecule and I want to study its PK in humans  Can anybody recommend a manual (available on the Internet at no charge) for such studies?  |
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DavidManteigas ★ Portugal, 2017-04-18 13:58 (2555 d 03:09 ago) @ BE-proff Posting: # 17246 Views: 3,565 |
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Hi BE-proff, Can anybody recommend a manual (available on the Internet at no charge) for such studies?The only ones I know are guidelines. All the others are paid. If you are looking for paid alternatives, there are a lot of specific literature on the subject, mainly for adaptive oncology clinical trials. |
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nobody nothing 2017-04-18 16:19 (2555 d 00:48 ago) @ BE-proff Posting: # 17247 Views: 3,654 |
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Hi! What are we talking about? First-in-man? Mass balance? Dose-escalation in healthy volunteers? If you have no experience (especially with the allometric scaling for first dose and necessary in vitro studies for tox/safety pharmacology/pk/metabolism) I would not even think about designing such trials based on "internet knowledge". Humans are not rats and rabbits. — Kindest regards, nobody |
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BE-proff ● 2017-04-19 10:35 (2554 d 06:32 ago) @ nobody Posting: # 17251 Views: 3,529 |
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Hi nobody, I was talking about First-in-man studies (healthy volunteers). |
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nobody nothing 2017-04-25 11:17 (2548 d 05:50 ago) @ BE-proff Posting: # 17261 Views: 3,395 |
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Hi! Here some appetizer http://www.clinbay.com/download/Presentations/2013-04-11_Phase_1_WS_Adaptive_Design.pdf ...but again: Don't do that at home. It's a complex, multidisciplinary process requiring much, much experience from preclinical and clincal (pharmacology) department  — Kindest regards, nobody |
Ing. Helmut Schütz