G. L. Drusano

Publication List Details

Period

1998 - 2007

Number

109

Co-Authors

Population pharmacokinetics at two dose levels and pharmacodynamic profiling of flucloxacillin (2007)

Landersdorfer, C. B., Kirkpatrick, C. M. J., Kinzig-Schippers, M., Bulitta, J. B., Holzgrabe, U., Drusano, G. L., ...

Flucloxacillin is often used for the treatment of serious infections due to sensitive staphylococci. The pharmacokinetic (PK)-pharmacodynamic (PD) breakpoint of flucloxacillin has not been determined...

Evaluation of Levofloxacin Pharmacodynamics in a Mouse Model of Inhalational Bacillus anthracis (2006)

Heine, H. S., Byrne, W. R., Bassett, J., Miller, L., Drusano, G. L.

See also ADM001851, Proceedings of the 2003 Joint Service Scientific Conference on Chemical & Biological Defense Research, 17-20 November 2003. , The original document contains color images.

Effective Antimicrobial Regimens for Use in Humans for Therapy of Bacillus anthracis Infections and Postexposure Prophylaxis (1998)

Deziel, Mark R., Heine, Henry, Louie, Arnold, Kao, Mark, Byrne, WIlliam R., Basset, Jennifer, ...

Expanded options for treatments directed against pathogens that can be used for bioterrorism are urgently needed. Treatment regimens directed against such pathogens can be identified only by using...

The Triple Combination Indinavir-Zidovudine-Lamivudine Is Highly Synergistic

Snyder, Stuart, D'Argenio, D. Z., Weislow, Owen, Bilello, John A., Drusano, G. L.

Administration of the combination of indinavir-zidovudine-lamivudine has been demonstrated to cause a large fraction of treated patients to have a decline in human immunodeficiency virus type 1...

Use of Drug Effect Interaction Modeling with Monte Carlo Simulation To Examine the Impact of Dosing Interval on the Projected Antiviral Activity of the Combination of Abacavir and Amprenavir

Drusano, G. L., D'Argenio, D. Z., Preston, S. L., Barone, C., Symonds, W., LaFon, S., ...

The delineation of optimal regimens for combinations of agents is a difficult problem, in part because, to address it, one needs to (i) have effect relationships between the pathogen in question and...

A Population Pharmacokinetic Analysis of the Penetration of the Prostate by Levofloxacin

Drusano, G. L., Preston, S. L., Van Guilder, M., North, D., Gombert, M., Oefelein, M., ...

Prostatitis has remained a pathological entity that is difficult to treat. Part of the difficulty revolves about the putative offending pathogens. For acute prostatitis, members of the...

Use of Preclinical Data for Selection of a Phase II/III Dose for Evernimicin and Identification of a Preclinical MIC Breakpoint

Drusano, G. L., Preston, S. L., Hardalo, C., Hare, R., Banfield, C., Andes, D., ...

One of the most challenging issues in the design of phase II/III clinical trials of antimicrobial agents is dose selection. The choice is often based on preclinical data from pharmacokinetic (PK)...

Pharmacodynamic Evaluation of RWJ-270201, a Novel Neuraminidase Inhibitor, in a Lethal Murine Model of Influenza Predicts Efficacy for Once-Daily Dosing

Drusano, G. L., Preston, S. L., Smee, D., Bush, K., Bailey, K., Sidwell, R. W.

We examined RWJ-270201 in a lethal model of influenza in BALB/c mice. The aim was to delineate the pharmacodynamically linked variable for the drug. Challenge was performed with influenza virus...

Nucleoside Analog 1592U89 and Human Immunodeficiency Virus Protease Inhibitor 141W94 Are Synergistic In Vitro

Drusano, G. L., D’Argenio, D. Z., Symonds, W., Bilello, P. A., McDowell, J., Sadler, B., ...

The use of combinations of anti-human immunodeficiency virus (anti-HIV) agents targeted to different molecular targets will most likely result in increased viral suppression and may also delay or...

Levofloxacin Penetration into Epithelial Lining Fluid as Determined by Population Pharmacokinetic Modeling and Monte Carlo Simulation

Drusano, G. L., Preston, S. L., Gotfried, M. H., Danziger, L. H., Rodvold, K. A.

Levofloxacin was administered orally to steady state to volunteers randomly in doses of 500 and 750 mg. Plasma and epithelial lining fluid (ELF) samples were obtained at 4, 12, and 24 h after the...

Pharmacodynamics of Abacavir in an In Vitro Hollow-Fiber Model System

Drusano, G. L., Bilello, P. A., Symonds, W. T., Stein, D. S., McDowell, J., Bye, A., ...

Abacavir is a potent new carbocyclic nucleoside analogue. We employed our hollow-fiber pharmacodynamic modeling system to examine the antiretroviral effects of different abacavir exposures, as well...

Rational Dose Selection for a Nonnucleoside Reverse Transcriptase Inhibitor through Use of Population Pharmacokinetic Modeling and Monte Carlo Simulation

Drusano, G. L., Moore, K. H. P., Kleim, J. P., Prince, W., Bye, A.

In order to choose a rational dose for GW 420867X, we first set a goal of therapy. We hypothesized that, for optimal antiretroviral activity, the trough free drug concentration should remain above...

Determination of robust ocular pharmacokinetic parameters in serum and vitreous humor of albino rabbits following systemic administration of ciprofloxacin from sparse data sets by using IT2S, a population pharmacokinetic modeling program.

Drusano, G L, Liu, W, Perkins, R, Madu, A, Madu, C, Mayers, M, ...

Robust determination of the concentration-time profile of anti-infective agents in certain specialized compartments is often limited by the inability to obtain more than a single sample from such a...

Population differences in ganciclovir clearance as determined by nonlinear mixed-effects modelling.

Yuen, G J, Drusano, G L, Fletcher, C, Capparelli, E, Connor, J D, Lalezari, J P, ...

We examined the pharmacokinetics of ganciclovir in different populations of cytomegalovirus (CMV)-infected patients through the use of nonlinear mixed-effects modelling. As expected, patient weight...

Efficacy of constant infusion of A-77003, an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease, in limiting acute HIV-1 infection in vitro.

Bilello, J A, Bilello, P A, Kort, J J, Dudley, M N, Leonard, J, Drusano, G L

A-77003, a human immunodeficiency virus type 1 (HIV-1) protease inhibitor, is effective for both acute and chronic infection in vitro and was evaluated clinically by continuous intravenous infusion...

Modeling combinations of antiretroviral agents in vitro with integration of pharmacokinetics: guidance in regimen choice for clinical trial evaluation.

Drusano, G L, Prichard, M, Bilello, P A, Bilello, J A

We propose a method for the selection of doses and dosing schedule for drugs to be used in combination. This approach uses the simulation of steady-state concentrations of the drugs in the...

Human serum alpha 1 acid glycoprotein reduces uptake, intracellular concentration, and antiviral activity of A-80987, an inhibitor of the human immunodeficiency virus type 1 protease.

Bilello, J A, Bilello, P A, Stellrecht, K, Leonard, J, Norbeck, D W, Kempf, D J, ...

The therapeutic utility of a human immunodeficiency virus type 1 (HIV-1) protease inhibitor may depend on its intracellular concentration, which is a property of its uptake, metabolism, and/or...

Modeling of the change in CD4 lymphocyte counts in patients before and after administration of the human immunodeficiency virus protease inhibitor indinavir.

Stein, D S, Drusano, G L

We investigated the relationships between changes in CD4 lymphocytes counts over 24 weeks after the initiation of therapy with indinavir at dosages of > or = 2.4 g/day (n = 15) in human...

Effect of renal function on the bioavailability of ciprofloxacin.

Plaisance, K I, Drusano, G L, Forrest, A, Weir, M R, Standiford, H C

The effect of renal function on the bioavailability of ciprofloxacin was studied in 21 subjects with measured creatinine clearances ranging from 0 to 8.99 liters/h per 1.73 m2. Each subject received...

Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate.

Plaisance, K I, Drusano, G L, Forrest, A, Townsend, R J, Standiford, H C

Interpretation of the majority of data on the disposition of clindamycin is confounded by the presence of active metabolites, which may interfere with commonly employed bioassays. We undertook a...

Synergism of the combinations of imipenem plus ciprofloxacin and imipenem plus amikacin against Pseudomonas aeruginosa and other bacterial pathogens.

Bustamante, C I, Drusano, G L, Wharton, R C, Wade, J C

The combinations of imipenem plus ciprofloxacin and imipenem plus amikacin were investigated for their activity against Pseudomonas aeruginosa and other bacterial pathogens. For imipenem-susceptible...

Bactericidal activity of ciprofloxacin compared with that of cefotaxime in normal volunteers.

Standiford, H C, Drusano, G L, Forrest, A, Tatem, B, Plaisance, K

We compared ciprofloxacin (200 mg) with cefotaxime (2 g) when each was administered intravenously over a 30-min period to six volunteers in a crossover manner 1 week apart. To integrate the...

Steady-state pharmacokinetics of imipenem in febrile neutropenic cancer patients.

Drusano, G L, Plaisance, K I, Forrest, A, Bustamante, C, Devlin, A, Standiford, H C, ...

We ascertained the pharmacokinetics of imipenem in febrile granulocytopenic cancer patients. The values observed were both different from and significantly more variable than those observed in normal...

Emergence of resistance to imipenem in Pseudomonas aeruginosa.

Lynch, M J, Drusano, G L, Mobley, H L

The emergence of resistance to imipenem by Pseudomonas aeruginosa was investigated with four pairs of isolates. Each pair represented pretherapy (susceptible) and posttherapy (resistant) specimens....

Relationships between renal function and disposition of oral ciprofloxacin.

Forrest, A, Weir, M, Plaisance, K I, Drusano, G L, Leslie, J, Standiford, H C

The relationships between creatinine clearance (CLCR) and the pharmacokinetics of oral ciprofloxacin were characterized. On the basis of these data, a dosage adjustment strategy, which incorporates...

Bactericidal activity of ceftazidime in serum compared with that of ticarcillin combined with amikacin.

Standiford, H C, Drusano, G L, Fitzpatrick, B, Tatem, B, Schimpff, S C

We compared the bactericidal activity of serum attained 1 and 6 h after the termination of infusions of either ceftazidime (2 g) or ticarcillin plus amikacin (5 g and 7.5 mg/kg, respectively) in 6...

Comparison of the pharmacokinetics of ceftazidime and moxalactam and their microbiological correlates in volunteers.

Drusano, G L, Standiford, H C, Fitzpatrick, B, Leslie, J, Tangtatsawasdi, P, Ryan, P, ...

We compared ceftazidime with moxalactam, a commonly utilized, currently available drug. The microbiological activities of ceftazidime and moxalactam were studied. In addition, single-dose...

Steady-state serum pharmacokinetics of novobiocin and rifampin alone and in combination.

Drusano, G L, Townsend, R J, Walsh, T J, Forrest, A, Antal, E J, Standiford, H C

Because of the potential of novobiocin-rifampin for oral therapy of methicillin-resistant Staphylococcus aureus infection, we evaluated the pharmacokinetics of novobiocin and rifampin, alone and in...

Double-blind, prospective, multicenter trial comparing ceftazidime with moxalactam in the treatment of serious gram-negative infections.

Joshi, M, Anthony, W C, Tenney, J H, Drusano, G L, Caplan, E S, Standiford, H C, ...

Ceftazidime is a new antimicrobial agent possessing excellent in vitro activity against most members of the family Enterobacteriaceae and against Pseudomonas aeruginosa. We conducted a double-blind,...

Postantibiotic effect of imipenem on Pseudomonas aeruginosa.

Bustamante, C I, Drusano, G L, Tatem, B A, Standiford, H C

Imipenem (formerly N-formimidoyl thienamycin) and ceftazidime were investigated for their postantibiotic effect on Pseudomonas aeruginosa. Four strains of P. aeruginosa in the logarithmic phase of...

Effect of saturable clearance during high-dose mezlocillin therapy.

Drusano, G L, Forrest, A, Fiore, D, Auger, F, Caplan, E S

As mezlocillin has been shown to display nonlinear pharmacokinetics in single-dose evaluations, we evaluated a crossover trial in patients with renal dysfunction the impact on serum clearance of...

Multiple-dose pharmacokinetics of imipenem-cilastatin.

Drusano, G L, Standiford, H C, Bustamante, C, Forrest, A, Rivera, G, Leslie, J, ...

We characterized the pharmacokinetic profile of imipenem-cilastatin administered intravenously to six normal volunteers in a dose of 1,000 mg of each drug every 6 h for 40 doses. The plasma...

Improved micromethod for mezlocillin quantitation in serum and urine by high-pressure liquid chromatography.

Fiore, D, Auger, F A, Drusano, G L, Dandu, V R, Lesko, L J

A rapid, sensitive, and specific method of analysis for mezlocillin in serum and urine by high-pressure liquid chromatography is described. A solid-phase extraction column was used to remove...

Pharmacokinetics of ceftazidime, alone or in combination with piperacillin or tobramycin, in the sera of cancer patients.

Drusano, G L, Joshi, J, Forrest, A, Ruxer, R, Standiford, H, Leslie, J, ...

We administered 2 g of ceftazidime intravenously every 8 h to cancer patients for the empiric therapy of febrile episodes. Ceftazidime was administered as monotherapy for patients with granulocyte...

Multiple-dose pharmacokinetics of ciprofloxacin administered intravenously to normal volunteers.

Gonzalez, M A, Moranchel, A H, Duran, S, Pichardo, A, Magana, J L, Painter, B, ...

We administered multiple doses of ciprofloxacin intravenously over 30 min every 12 h for 1 week to nine healthy volunteers. Three volunteers received a placebo (vehicle) intravenously. Doses of 100,...

In vitro susceptibility of pathogenic Vibrio species to norfloxacin and six other antimicrobial agents.

Morris, J G, Tenney, J H, Drusano, G L

The in vitro activity of norfloxacin and six other antimicrobial agents was tested against 93 vibrio strains representing the currently described pathogenic Vibrio species. Norfloxacin had excellent...

Imipenem coadministered with cilastatin compared with moxalactam: integration of serum pharmacokinetics and microbiologic activity following single-dose administration to normal volunteers.

Standiford, H C, Drusano, G L, Bustamante, C I, Rivera, G, Forrest, A, Tatem, B, ...

We administered 1 g of imipenem along with equal amounts of cilastatin (a dehydropeptidase I inhibitor) or 2 g of moxalactam intravenously over a period of 30 min to six volunteers in a crossover...

Dose ranging study and constant infusion evaluation of ciprofloxacin.

Drusano, G L, Plaisance, K I, Forrest, A, Standiford, H C

We evaluated the pharmacokinetics of 100- and 200-mg doses of ciprofloxacin, with the 200-mg dose administered either as a 30-min infusion or as a 100-mg loading dose followed by a 4-h constant...

Absolute oral bioavailability of ciprofloxacin.

Drusano, G L, Standiford, H C, Plaisance, K, Forrest, A, Leslie, J, Caldwell, J

We evaluated the absolute bioavailability of ciprofloxacin, a new quinoline carboxylic acid, in 12 healthy male volunteers. Doses of 200 mg were given to each of the volunteers in a randomized,...

Lactobacillus prophylaxis for diarrhea due to enterotoxigenic Escherichia coli.

Clements, M L, Levine, M M, Black, R E, Robins-Browne, R M, Cisneros, L A, Drusano, G L, ...

In vitro and animal experiments indicated that lactobacilli might prevent Escherichia coli from colonizing the intestine and may produce substances counteracting enterotoxin. Lactinex, a commercial...

Optimal Sampling Schedule Design for Populations of Patients

Tam, Vincent H., Preston, Sandra L., Drusano, G. L.

Generation of pharmacodynamic relationships in the clinical arena requires estimation of pharmacokinetic parameter values for individual patients. When the target population is severely ill, the...

Preclinical evaluation of antiviral activity and toxicity of Abbott A77003, an inhibitor of the human immunodeficiency virus type 1 protease.

Kort, J J, Bilello, J A, Bauer, G, Drusano, G L

A synthetic, symmetry-based inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease, A77003, was evaluated for antiviral activity and cytotoxicity in vitro in human peripheral blood...

Pharmacodynamics of a fluoroquinolone antimicrobial agent in a neutropenic rat model of Pseudomonas sepsis.

Drusano, G L, Johnson, D E, Rosen, M, Standiford, H C

We examined the impact of dose fractionation and altered MICs on survivorship in a neutropenic rat model of Pseudomonas aeruginosa sepsis employing the new fluoroquinolone antibiotic lomefloxacin....

Effect of 2',3'-didehydro-3'-deoxythymidine in an in vitro hollow-fiber pharmacodynamic model system correlates with results of dose-ranging clinical studies.

Bilello, J A, Bauer, G, Dudley, M N, Cole, G A, Drusano, G L

We sought to validate an in vitro system which could predict the minimal effect dose of antiretroviral agents. Mixtures of uninfected CEM cells and CEM cells chronically infected with human...

Impact of bioavailability on determination of the maximal tolerated dose of 2',3'-dideoxyinosine in phase I trials.

Drusano, G L, Yuen, G J, Morse, G, Cooley, T P, Seidlin, M, Lambert, J S, ...

The objective of this study was to determine the population pharmacokinetic parameters and the extent of absorption of 2',3'-dideoxyinosine, a nucleoside analog with activity against human...

Use of human renal proximal tubule cell cultures for studying foscarnet-induced nephrotoxicity in vitro.

Trifillis, A L, Cui, X, Drusano, G L

Foscarnet is an antiviral agent used for the treatment of cytomegalovirus retinitis and acyclovir-resistant herpes simplex virus infections in AIDS patients. Renal impairment has been reported for...

Measurement of amikacin in serum by a latex agglutination inhibition test.

Khabbaz, R F, Standiford, H C, Bernstein, D, Nipper, H C, Tatem, B A, Smalls, U, ...

Levels of amikacin in serum were determined in 106 serum specimens by a latex agglutination inhibition card test and by radioimmunoassay (RIA). Linear regression analysis demonstrated a high degree...

Pharmacokinetics of intravenously administered ciprofloxacin in patients with various degrees of renal function.

Drusano, G L, Weir, M, Forrest, A, Plaisance, K, Emm, T, Standiford, H C

We examined the pharmacokinetic behavior of 200 mg of ciprofloxacin administered intravenously to 32 volunteers whose renal function as measured by creatinine clearance ranged from 0 to 8.99 liters/h...

Effect of dose size on bioavailability of ciprofloxacin.

Plaisance, K I, Drusano, G L, Forrest, A, Bustamante, C I, Standiford, H C

We evaluated the bioavailability of ciprofloxacin at two dose sizes in eight healthy volunteers. Each volunteer was given 200 mg of ciprofloxacin both orally and intravenously in a randomized...

Impact of dosing schedule upon suppression of a retrovirus in a murine model of AIDS encephalopathy.

Bilello, J A, Eiseman, J L, Standiford, H C, Drusano, G L

We studied the impact of zidovudine (AZT) in Cas-Br-M murine leukemia virus-infected NFS-N mice after administration by once-daily bolus or continuous infusion. While higher peak concentrations of...

Quantitative relationships between zidovudine exposure and efficacy and toxicity.

Drusano, G L, Balis, F M, Gitterman, S R, Pizzo, P A

We examined the relationship between the concentrations of zidovudine in plasma given by continuous intravenous infusion to human immunodeficiency virus-positive pediatric patients and a surrogate...

Pharmacodynamic Evaluation of Extending the Administration Time of Meropenem using a Monte Carlo Simulation

Lomaestro, Ben M., Drusano, G. L.

A Monte Carlo simulation demonstrated that 1 g of meropenem (MEM) every 8 h (q8h) (3-h infusion) has a higher target attainment rate against Pseudomonas aeruginosa than either 500 mg of MEM q8h (3-h...

Effective Antimicrobial Regimens for Use in Humans for Therapy of Bacillus anthracis Infections and Postexposure Prophylaxis†

Deziel, Mark R., Heine, Henry, Louie, Arnold, Kao, Mark, Byrne, William R., Basset, Jennifer, ...

Expanded options for treatments directed against pathogens that can be used for bioterrorism are urgently needed. Treatment regimens directed against such pathogens can be identified only by using...

Comparative Pharmacokinetics and Pharmacodynamic Target Attainment of Ertapenem in Normal-Weight, Obese, and Extremely Obese Adults

Chen, M., Nafziger, A. N., Drusano, G. L., Ma, L., Bertino, J. S.

Little is known of the effects of obesity on ertapenem drug disposition and pharmacodynamics. Thirty healthy volunteers in three body mass index (BMI) groups (10 per group), normal weight (BMI, 18.5...

The Triple Combination Indinavir-Zidovudine-Lamivudine Is Highly Synergistic

Snyder, Stuart, D'Argenio, D. Z., Weislow, Owen, Bilello, John A., Drusano, G. L.

Administration of the combination of indinavir-zidovudine-lamivudine has been demonstrated to cause a large fraction of treated patients to have a decline in human immunodeficiency virus type 1...

Use of Drug Effect Interaction Modeling with Monte Carlo Simulation To Examine the Impact of Dosing Interval on the Projected Antiviral Activity of the Combination of Abacavir and Amprenavir

Drusano, G. L., D'Argenio, D. Z., Preston, S. L., Barone, C., Symonds, W., LaFon, S., ...

The delineation of optimal regimens for combinations of agents is a difficult problem, in part because, to address it, one needs to (i) have effect relationships between the pathogen in question and...

A Population Pharmacokinetic Analysis of the Penetration of the Prostate by Levofloxacin

Drusano, G. L., Preston, S. L., Van Guilder, M., North, D., Gombert, M., Oefelein, M., ...

Prostatitis has remained a pathological entity that is difficult to treat. Part of the difficulty revolves about the putative offending pathogens. For acute prostatitis, members of the...

Use of Preclinical Data for Selection of a Phase II/III Dose for Evernimicin and Identification of a Preclinical MIC Breakpoint

Drusano, G. L., Preston, S. L., Hardalo, C., Hare, R., Banfield, C., Andes, D., ...

One of the most challenging issues in the design of phase II/III clinical trials of antimicrobial agents is dose selection. The choice is often based on preclinical data from pharmacokinetic (PK)...

Pharmacodynamic Evaluation of RWJ-270201, a Novel Neuraminidase Inhibitor, in a Lethal Murine Model of Influenza Predicts Efficacy for Once-Daily Dosing

Drusano, G. L., Preston, S. L., Smee, D., Bush, K., Bailey, K., Sidwell, R. W.

We examined RWJ-270201 in a lethal model of influenza in BALB/c mice. The aim was to delineate the pharmacodynamically linked variable for the drug. Challenge was performed with influenza virus...

Nucleoside Analog 1592U89 and Human Immunodeficiency Virus Protease Inhibitor 141W94 Are Synergistic In Vitro

Drusano, G. L., D’Argenio, D. Z., Symonds, W., Bilello, P. A., McDowell, J., Sadler, B., ...

The use of combinations of anti-human immunodeficiency virus (anti-HIV) agents targeted to different molecular targets will most likely result in increased viral suppression and may also delay or...

Levofloxacin Penetration into Epithelial Lining Fluid as Determined by Population Pharmacokinetic Modeling and Monte Carlo Simulation

Drusano, G. L., Preston, S. L., Gotfried, M. H., Danziger, L. H., Rodvold, K. A.

Levofloxacin was administered orally to steady state to volunteers randomly in doses of 500 and 750 mg. Plasma and epithelial lining fluid (ELF) samples were obtained at 4, 12, and 24 h after the...