bharathi
☆    

India,
2013-02-13 12:36
(4885 d 08:44 ago)

Posting: # 10010
Views: 3,106
 

 Endogenous analyte - LOQ is high [Regulatives / Guidelines]

Thanks for the forum and the informative data sharing..

We are dealing with one of the endogenous compound. LOQ is high nearly 1 ng/mL where as Cmax itself is around 8-9ng/mL

We asked many BE labs in India and we couldn't get a bioanalytical method which is sensitive to the acceptable extent.

One of the lab offered a method with 0.25 ng/mL with some interferences.
Is this acceptable (i.e with interferences)? If it is acceptable, do we need to do any corrections?

Does using internal standard help to any extent?

Thanks again for HELMUT for having such a fabulous Forum..

Regards,
Bharathi
ElMaestro
★★★

Denmark,
2013-02-13 13:27
(4885 d 07:52 ago)

@ bharathi
Posting: # 10011
Views: 2,598
 

 Endogenous analyte - LOQ is high

Hello bharahti,

❝ We are dealing with one of the endogenous compound. LOQ is high nearly 1 ng/mL where as Cmax itself is around 8-9ng/mL

❝ One of the lab offered a method with 0.25 ng/mL with some interferences.

❝ Is this acceptable (i.e with interferences)? If it is acceptable, do we need to do any corrections?


Before I try to guess wildly at this I'd like to hear what the normal endogenous range is (min, max). Could you comment?

❝ Does using internal standard help to any extent?


Is this done by chromatography? If so then I think it is almost unusual if there's no internal standard.

Pass or fail!
ElMaestro
jag009
★★★

NJ,
2013-02-13 16:37
(4885 d 04:43 ago)

@ bharathi
Posting: # 10014
Views: 2,614
 

 Endogenous analyte - LOQ is high

Hi,

❝ We are dealing with one of the endogenous compound. LOQ is high nearly 1 ng/mL where as Cmax itself is around 8-9ng/mL


❝ Does using internal standard help to any extent?


Just one question, your study design will involve pre-exposure to establish a baseline (for correction) before administering the drug in each period right?

Since I don't know your compound, if the method uses ICP-MS, then no internal standard.

John
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