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RK ☆ India, 2013-08-29 16:27 (3891 d 13:31 ago) Posting: # 11381 Views: 3,837 |
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Dear All, Suppose we have data for 12 subjects, with two timepoints - Predose and one postdose (0-24 hrs post dose). Is it possible to estimate the PK parameters. What is the minimum number of timepoints required for urine PK estimation. Regards, RK Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2013-08-29 16:52 (3891 d 13:06 ago) @ RK Posting: # 11383 Views: 3,200 |
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Hi RK, ❝ […] two timepoints - Predose and one postdose (0-24 hrs post dose). Is it possible to estimate the PK parameters. I assume your drug is not an endogenous compound. Therefore, you could only calculate Ae24. Since you have no previous samples (in the absorption phase) you have no clue whether excretion is – more or less – complete or not. Doesn’t make any sense. ❝ What is the minimum number of timepoints required for urine PK estimation. You have to calculate the maximum excretion rate as well – which is tricky. In my experience the minimum are ~six samples. Since the rate is rather difficult to calculate from urine data, EMA wants to see Cmax from plasma anyway. — 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 |
Ing. Helmut Schütz