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Hello All:
We are conducting a human drug-drug interaction study and one of the
objectives of our study is to determine the effect of our drug on a P-
gp substrate. I understand that we have to determine the genotype of
P-gp expressed in the subjects. Can someone who has experience with
these kinds of studies let me know how to proceed with the genotype
testing? Are there any CROs that have the capability? Please note, we
are not looking for a CRO to conduct the DDI study for us; we already
have that nailed down. Now, we are looking for someone who can help
us with P-gp genotyping.
Thanks
Girish
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The following message was posted to: PharmPK
Dear Girish,
If you are interested in Genotyping polymorphism using SNP as a
marker I
can suggest you some CRO in India.
Cheers
praveen
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Girish,
ABI biosystems had PCR-based custom-made allelic-discrimination based
polymorphism assays for P-gp genotyping. The assays are cheap,
straight forward and can be done in a day. All one needs is access to
a q-PCR machine and/or sequencing capability.
You have to note that P-gp pharmacogenetic literature is vast and
ambigious when it comes to clear genotype-phenotype corelations.
Which particular SNP (C3435 T or G2677C) or the haplotype and
population cohort are you looking for?
USFDA is recommending ( not mandating) that subjects be genotyped for
studies on P-gp substrates. However, there are no clear cut
guidelines and every company has to self-regulate their studies to
add value and content to the clinical design.
Hope this helps I can provde further help if you want to contact
further.
Regards,
Santosh
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The following message was posted to: PharmPK
Girish:
There are several companies out there that provide genotyping services
at various costs for those services. Assuming you have access to Taqman
equipment, Applied Biosystems has several drugs metabolizing and
transporter genotyping kits available for purchase. You can also custom
design your own assays based on your alleles of interest. I recently
genotyped for 2-3 PGP SNPs using either predesiged or custom designed
ABI assays and had good results. Contact me directly if you need any
specific details.
Sincerely,
Melanie S. Joy, Pharm.D., FCCP
Associate Professor
UNC School of Medicine
Division of Nephrology and Hypertension
UNC Kidney Center
CB #7155, 7005 Burnett Womack Building
Chapel Hill, NC 27599-7155
919-966-2561 ext 259 (phone)
919-966-4251 (fax)
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