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Dear All,
please tell me for statistical analysis of Bioequivalence study ,i
received data from analytical dept. which contains only two/three
measurable concentrations in all 24 sample points remaining are zero/
BlQ:below LLOQ.
-Mrudula
Biostatistician
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This can be a poorly run study case!!
Accutest Punewrote:
PharmPK - Discussions about Pharmacokinetics
Pharmacodynamics and related topics
Dr. Mandar Mote
Head Bio-analytical
CRO
Cadila Pharmaceuticals Ltd.
Ahmedabad.
[a pilot study and/or some 'simple' simulations should have preceded
a full study? - db]
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Dear Mrudula,
This is not a statistical problem. It is impossible to get
basic PK parameters, such as Cmax, Tmax, AUC. Yes. If all data points
were zero, they are bioequivalent. (:), joke). I met bad data before
and sent it back.
Best regards,
Ma Guangli
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The following message was posted to: PharmPK
LC or Ligand binding? You can reformat the assay. If LC, and volume
is not an issue, increase the injection volume. IF possible, re extract
samples and resuspend to concentrate samples. If UV- go to 210, if MS
use total Ion, you can also modify the column- go to a shorter, narrower
column, perhaps try an on/off gradient.
If Ligand binding, use less dilution for the assay or extract and
concentrate. you can also adjust the capture and detect to push
sensitivity.
You would need to re-validate. Generally, analytical methods are
developed driven by the PK people who identify a usuable LLOQ and ULOQ
for the assay. DO the assay results make sense for the dose of drug
given and the sampling times chosen?
If the assay was developed using faulty targets for LLOQ, the targets
need to be better identified and the assay redeveloped based on more
accurate definitions of the needed LLOQ.
Ed O'Connor, PhD
Technical Director, Immunoanalytical
Tandem Laboratories
115 Silvia Street
West Trenton, New Jersey
609-228-0243
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The following message was posted to: PharmPK
I believe there is an entire body of stats dealing with similarity and
non dissimilarity-bioequalence. Graphpad offers a very lucent
discussion of this subject and it free.
Ed O'Connor, PhD
Technical Director, Immunoanalytical
Tandem Laboratories
115 Silvia Street
West Trenton, New Jersey
609-228-0243
[A good start might be http://www.graphpad.com/index.cfm?
cmd=library.index - db]
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