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I need some info regarding the Bioanalytical method validation.
How much % recovery of the drug from the plasma is normally acceptable?
Does this vary from drug to drug?
Regards
Vardhini
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Hi,
I think there is no minimum recovery for a drug as long as one can
quantify (i.e., recovery should be above LOQ) the recovered drug and
the recovery is reproducible. But it is advisable to have higher
recovery to be at safeside regarding reproducibility.
hope this helps!
Nag.
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The following message was posted to: PharmPK
Dear Nageshwar!
>How much % recovery of the drug from the plasma is normally acceptable?
>
If you are able to validate the method according to current standards,
everything is fine (i.e., there is no 'lower limit' of recovery per se).
>Does this vary from drug to drug?
>
Yes, and from method to method, lab to lab, country to country ... ;-)
Regards
Helmut
--
Helmut Schutz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
A-1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at Bioequivalence/Bioavailability Forum at
http://forum.bebac.at
http://www.goldmark.org/netrants/no-word/attach.html
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The following message was posted to: PharmPK
Vardhini:
There is no formal cut off in any guidance for the extraction recovery
FDA
Guidance states: "Recovery of the analyte need not be 100%, but the
extent
of recovery of an analyte and the internal standard should be
consistent,
precise and reproducible"
Having said this: Recovery of a compound reflects on the sensitivity
accuracy and precision of your method imagine if your method recovery is
only 20%, then you may be dealing with an inefficient method. During
the
Crystal City workshop there was a mention that recovery should be at
least
50% or above. You can be lenient as far as internal standard recovery,
but
you should develop a extraction method that yields high recovery (80 -
90%)
so that other headaches in the actual analysis will pop up.
Hope this explanation will help your work.
Sincerely,
Prasad Tata
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I would like to add that higher the recovery lower will be the
deviation. This applies to both analyte and internal standard. However,
more than percent recovery it is important to have similar recovery for
both analyte and internal standard in which case one can get away with
the recoveries as low as 50%.
Hope this helps.
Kasiram.
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