Bioequivalence and Bioavailability Forum • Pharmacokinetic repeats

Roshini
☆

2008-02-05 06:24
(6717 d 01:56 ago)

Posting: # 1581
Views: 4,892

Pharmacokinetic repeats [Bioanalytics]

Dear Members,

I have a doubt in pharmacokinetic repeats.

When last time point shows a concentration which is above limit of quantification and is higher than the previous time point even after repeating.

Which of the following values should be taken for final pharmacokinetic and statistical calculation:
1. should we drop this time point.
2. Take the original value itself
3. Take the mean of the original value and the repeat value

If we want to put some criteria to address this issue in our SOP. What should we write in the SOP.

Thanks and Regards,

Roshini Singh

hsan
●

2008-02-05 12:43
(6716 d 19:38 ago)

@ Roshini
Posting: # 1586
Views: 3,883

Pharmacokinetic repeats

Post reply

1. The final value for the time point depends on how you defined the SOP. But it is not good the ommit the value altogether. All the criteria listed by you may be adopted. But this should be preferrably treated like any other repeat value.

2. The only difference is you should not include this subject for calculating AUCinf. This should be predefined in protocol/SOP.

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Edit: Full quote removed. Please see this post! [Helmut]

ShankarCL ● 2008-03-04 09:22 (6688 d 22:59 ago) @ hsan Posting: # 1656 Views: 3,758	Pharmacokinetic repeats Post reply
	Dear hsan, For the Point 2, I have'nt come across any protocol stating the same. Besides not incuding the subject for AUCinf calculations would be like bias even if mentioned in the protocol. Kindly let me know your opinion. Shankar