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Division of Clinical Pharmacology
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The Alan Bernstein Laboratories conduct a spectrum of work that ranges from selecting or creating an appropriate analytical method for detecting drug/metabolite in clinical samples; to implementing, standardizing, and executing quantitative measurements; and finally to pharmacokinetic analysis of the data obtained. The laboratories comprise 2,500 square feet of space and are well equipped for processing and analyzing samples obtained in human studies. This includes sample processing; diverse analytical methodologies; tissue culture; and molecular biology. The laboratories currently have the capacity for multiple methods of drug analysis, including spectrophotometric assays, radio-enzymologic assays, radioimmunoassays, and HPLC-UV and HPLC-MS assays. The facilities are approved by the Johns Hopkins University Biosafety Office for work involving cells and fluids from HIV-infected subjects, and for work with live recombinant vaccinia viruses, herpes simplex viruses, human cytomegalovirus, African trypanosomes and malaria parasites.

An Applied Biosystems API4000 LC-MS/MS instrument is housed in the Division of Clinical Pharmacology laboratories. The majority of instrument time is dedicated to quantitation of antiretroviral agents used in the treatment of HIV/AIDS. LC-MS/MS analysis provides the highest degree of sensitivity, selectivity and sample throughput and is ideal for determination of the pharmacokinetics of combinations of antiretroviral agents employed in the management of HIV/AIDS. The remaining instrument time is dedicated to quantitation and identification of small molecules of interest to other investigators within the Hopkins community and non-Hopkins institutions.

The Pharmacokinetic/Pharmacodynamic Laboratory is equipped with three semi-automated pharmacokinetic/pharmacodynamic systems. At the heart of these "cartridge systems" is a bundle of hundreds of semipermeable hollow fibers that traverse a closed cylinder, effectively dividing the cylinder contents into two compartments (intrafiber and extrafiber) between which small molecules freely exchange. Cells are introduced and maintained in the extrafiber compartment and medium containing the desired concentrations of study drug flows continuously through the fibers. Dynamic drug levels are obtained by a series of programmable pumps and reservoirs. Throughout the experiment aliquots of cells may be tapped and assayed for the pharmacodynamic endpoint(s). The system can mimic first order human pharmacokinetics and it allows the simulation of doses and dosing regimens of choice, against microbes of interest (including intracellular viruses).

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Analytical Lab
Analytical Lab
Virtually all our clinical studies depend upon analytical laboratory data

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