Bioequivalence and Bioavailability Forum

Dr. Harish L. Rao
☆

India,
2009-06-25 10:54
(5792 d 07:05 ago)

(edited on 2009-06-25 18:03)
Posting: # 3900
Views: 6,501

Truncation of values close to LOQ [NCA / SHAM]

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Dear Group Members,

In a oral PK profile if we have values close & above the LOQ at the elimination phase,

Can we eliminate these values during calculation of PK parameters?
In case we eliminate these timepoints, should we use AUC (0-last) or AUC (0-inf.) for calculation of bioavailability / bioequivalence?
If so, it is essential that the last time point be same in both cases (test & reference) during comparisons?
Is there any guideline for elimination of such time points close & above LOQ in the elimination phase?

Thanks & regards,
Dr. Harish L. Rao

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Edit: category changed [Ohlbe]

Ohlbe
★★★

France,
2009-06-25 12:08
(5792 d 05:50 ago)

@ Dr. Harish L. Rao
Posting: # 3902
Views: 5,198

Above LOQ is above LOQ

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Dear Dr Harish,

Above LOQ is above LOQ, even if close to it... Either you think there is a problem with your bioanalytical method and these low concentrations are not reliable despite what you found in your pre-study validation, in which case you may need to modify your method and re-validate it, or your method is OK and you can't ignore these values just because you don't like them.

Regards
Ohlbe

ElMaestro ★★★ Denmark, 2009-06-25 17:17 (5792 d 00:41 ago) @ Ohlbe Posting: # 3906 Views: 5,115	Above LOQ is above LOQ Post reply
	Agree with Ohlbe. Marcel Pagnol, who beyond reasonable doubt had bioanalysis in mind when he wrote L'eau des collines, expressed his view the following way (if my memory serves me right): "Quand on a commencé a faire étrangler le chat, il faut le finir". Sadly enough, I am unaware of any Belgian writers expresing anything relevant to BA/BE. But I'll keep thinking. EM.

Helmut ★★★ Vienna, Austria, 2009-06-25 17:46 (5792 d 00:13 ago) @ ElMaestro Posting: # 3907 Views: 5,178	Belgian... Post reply
	Oh dear! When it comes to Belgian authors - nothing about BE, but one of my favourite books is Hygiène de l'assassin by Amélie Nothomb. — 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

Truncation of values close to LOQ [NCA / SHAM]

Above LOQ is above LOQ

Above LOQ is above LOQ

Belgian...