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PVRC ☆ India, 2021-04-23 09:24 (1415 d 00:15 ago) Posting: # 22312 Views: 4,208 |
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Dear All, I have a question on the inclusion of a subject with missing three consecutive sampling points in the elimination phase. The subject followed the procedures through 8 hr sampling points and left for an emergency. The half life of the drug is 12 hours. the subject is willing to join the next periods. Whether that subject will be included in the PK analysis and /or statistical analysis if allowed in the next periods ? Thanks in advance with best regards PVRC Edit: Category changed; see also this post #1. [Helmut] |
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ElMaestro ★★★ Denmark, 2021-04-23 10:40 (1414 d 22:59 ago) @ PVRC Posting: # 22313 Views: 3,452 |
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Hi PVRC, ❝ I have a question on the inclusion of a subject with missing three consecutive sampling points in the elimination phase. The subject followed the procedures through 8 hr sampling points and left for an emergency. The half life of the drug is 12 hours. the subject is willing to join the next periods. Whether that subject will be included in the PK analysis and /or statistical analysis if allowed in the next periods ? Isn't that the wrong question? I mean why would you include the subject for period 2 if not using her/his data? For production of tolerance/safety data only? The question is more likely whether or not the subject should be invited to complete the study. I think she/he should, if you can make of her/his data. Three missings in the elimination phase is not a show-stopper, however annoying it may be. If you do not have SOPs or a protocol that somehow provides for exclusion I think the subject is still in the study. At some CROs a subject going home in period 1 on own will or due to an AE is a lost/discontinued subject, while at other CROs subjects can come back for period 2 in such cases. It isn't a situation that is well defined by guidance. Good luck with the rest of the study.  — Pass or fail! ElMaestro |
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PVRC ☆ India, 2021-04-23 12:19 (1414 d 21:20 ago) @ ElMaestro Posting: # 22314 Views: 3,493 |
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Hi ElMaestro, Thank you for the reply, ❝ The question is more likely whether or not the subject should be invited to complete the study. I think she/he should, if you can make of her/his data. Three missings in the elimination phase is not a show-stopper, however annoying it may be. If the AUC0-t is not affected by the missing sample in the elimination phase can the data from such a subject be considered for analysis..? with best regards PVRC |
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Helmut ★★★   Vienna, Austria, 2021-04-23 12:34 (1414 d 21:05 ago) @ PVRC Posting: # 22316 Views: 3,481 |
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Hi PVRC, ❝ If the AUC0-t is not affected by the missing sample in the elimination phase can the data from such a subject be considered for analysis..? What does your protocol say? It boils down how long you sampled. See also this article, esp. the section about Missings. With a half life of 12 hours and the last sample at 8 hours in the first period, a comparison of AUC0–t will be biased. Essentially you have two options:
— 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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Ohlbe ★★★ France, 2021-04-23 16:50 (1414 d 16:49 ago) @ PVRC Posting: # 22321 Views: 3,458 |
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Dear PVRC, ❝ The subject followed the procedures through 8 hr sampling points and left for an emergency. The half life of the drug is 12 hours. What we're missing here is the expected tmax. What does the reference information of the reference product say ? If you have past experience on the same active substance, what was the latest tmax you had ? You might keep the subject and use his data for Cmax but not for AUC. Considering the little impact that one single subject will have on power, I would however rather consider him as a drop out and avoid potential nasty discussions. This being said, if this is for the same 4-treatment William's design study for which you posted other messages today, it might be possible to exclude this period and keep his data for the other 3. If so, this must be defined and documented now, before the next period. — Regards Ohlbe |
Ing. Helmut Schütz