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I would appreciate any information on clinical units that have experience
in conducting pharmacokinetic/pharmacodynamic studies in renally
impaired
patients. Comments on positive or negative experience with these
studies
would also be welcome.
Nishit B. Modi, Ph.D.
phone :(415) 225-3265
fax : (415) 225-6452
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Dr. Mody,
University of Pittsburgh School of Pharmacy is good at this type of
studies the group you can contact on this type of study and PK/PD
studies in hepatic impaired patient population are
Venkat/Burckart/matzke. The following are their Tel. No.
Professor Raman Venkataramanan (412) 648-8547
Professor Gilbert Burckart (412) 648-8559
Professor Gary Matzke (412) 624-8153
Clinical Pharmacokinetics lab (412) 648-8534
This is a good lab. doing many of PK studies
If you need any further info please contact me.
Prasad Tata, Ph.D.
Otsuka America Pharmaceuticals Inc.
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CHDR Leiden performs these studies. We have a link with the
department of nephrology where the CHDR director is visiting staff
member. We have performed studies in transplant patients, pancreas-
kidney transplant patients, studies of pharmacokinetics in relation
to renal function and studies in dialysis.
CHDR also will supply pharmacokinetic and clinical consultancy
regarding these studies and can perform them in its purpose built
GCP compatible research unit close to the Leiden University Hospital.
Assay facilities for the pharmacokinetic evaluation can be arranged
through our partner TNO which has the full range of GLP capabilities
including LC-MS.
Please let us know if you want to explore this further.
Prof dr A F Cohen
Director Centre for Human Drug Research
Zernikedreef 10
2333CL Leiden
the Netherlands
telephone +31 71 524 6404
fax +31 71 524 6499
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