NK ☆ India, 2024-01-19 05:24 (539 d 04:13 ago) Posting: # 23832 Views: 4,497 |
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Dear All, We are planning a steady state bioequivalence study on healthy subject with tid dosing (every 8 hours) on day 1 to day 4. Serial PK blood sample collections are planned on Day 5 after morning dosing(expected to reach steady state concentration on day 5). Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours? Thanks in advance! Regards NK Edit: Category changed; see also this post #1. [Helmut] |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2024-01-20 13:50 (537 d 19:47 ago) @ NK Posting: # 23834 Views: 3,762 |
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Hi NK, ❝ We are planning a steady state bioequivalence study on healthy subject with tid dosing (every 8 hours) on day 1 to day 4. Serial PK blood sample collections are planned on Day 5 after morning dosing(expected to reach steady state concentration on day 5). ❝ Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours? — 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 |
dshah ★★ India, 2024-01-22 11:09 (535 d 22:29 ago) @ NK Posting: # 23837 Views: 3,830 |
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Hi NK! ❝ Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours? So you are asking for protocol preparation consideration. The study is in healthy volunteers- so I believe that AUC0-t/AUC0-inf>=0.8 also needs to be followed, so consider sampling accordingly. Regards, Divyen |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2024-01-27 23:01 (530 d 10:36 ago) @ dshah Posting: # 23842 Views: 3,408 |
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Hi Divyen, ❝ So you are asking for protocol preparation consideration. The study is in healthy volunteers- so I believe that AUC0-t/AUC0-inf>=0.8 also needs to be followed, so consider sampling accordingly. — 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 |
dshah ★★ India, 2024-01-27 23:06 (530 d 10:31 ago) @ Helmut Posting: # 23843 Views: 3,402 |
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Hi Helmut! Thank you for correcting me. Seems an EMA Study because of steady state requirement. Regards, Divyen |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2024-01-27 23:16 (530 d 10:21 ago) @ dshah Posting: # 23844 Views: 3,356 |
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Hi Divyen, ❝ Thank you for correcting me. ![]() Background and some ideas. — 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 |