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1

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Effects of antibiotic resistance, drug target attainment, bacterial pathogenicity and virulence, and antibiotic access and affordability on outcomes in neonatal sepsis: an international microbiology and drug evaluation prospective substudy (BARNARDS)

Thomson, Kathryn M ; Dyer, Calie ; Liu, Feiyan ; [et al.]

Elsevier BV ; 2021

In: The Lancet Infectious Diseases Vol. 21, No. 12 ( 2021-12), p. 1677-1688

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In: The Lancet Infectious Diseases, Elsevier BV, Vol. 21, No. 12 ( 2021-12), p. 1677-1688

Type of Medium: Online Resource

ISSN: 1473-3099

URL: Article

DOI: 10.1016/S1473-3099(21)00050-5

Language: English

Publisher: Elsevier BV

Publication Date: 2021

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Pharmacodynamic Profiling of Ceftobiprole for Treatment of Complicated Skin and Skin Structure Infections

Kimko, Holly ; Xu, Xu ; Nandy, Partha ; [et al.]

American Society for Microbiology ; 2009

In: Antimicrobial Agents and Chemotherapy Vol. 53, No. 8 ( 2009-08), p. 3371-3374

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In: Antimicrobial Agents and Chemotherapy, American Society for Microbiology, Vol. 53, No. 8 ( 2009-08), p. 3371-3374

Abstract: Ceftobiprole, a broad-spectrum cephalosporin with activity against methicillin (meticillin)-resistant staphylococci, was statistically noninferior to a combination of vancomycin plus ceftazidime in patients with complicated skin and skin structure infections (cSSSI). This analysis used data from this clinical trial to determine the relationship between therapeutic outcome and the percentage of time that the unbound ceftobiprole concentration exceeds the MIC (percent T 〉 MIC). From the trial of ceftobiprole (500 mg every 8 h, 2-h infusion) for cSSSI due to gram-positive and/or gram-negative bacteria, data from 309 patients in the microbiological intent-to-treat analysis set with measured ceftobiprole concentrations and baseline MICs were used to assess the relationship between percent T 〉 MIC and therapeutic outcome. Individual pharmacokinetic (PK) profiles were obtained from a three-compartment population PK model. The relationship between percent T 〉 MIC and a clinical cure was determined. For the clinical trial dosing regimen, individual percent T 〉 MICs were used to calculate fractional target attainment rates (TARs) for ≥30 and ≥50% T 〉 MIC targets at various MICs. There was a statistically significant relationship between achieving a ≥30 or ≥50% T 〉 MIC and a clinical cure ( P = 0.003 and P = 0.007, respectively; Pearson's χ 2 test). The fractional TAR was greater than 90% at a MIC of ≤4 mg/liter for patients with normal renal function. A relationship between percent T 〉 MIC and a clinical cure with ceftobiprole was demonstrated. A ceftobiprole regimen of 500 mg every 8 h as a 2-h infusion has a high probability of achieving a target of ≥30 or ≥50% T 〉 MIC for patients with cSSSI due to gram-positive and gram-negative pathogens.

Type of Medium: Online Resource

ISSN: 0066-4804 , 1098-6596

URL: Article

DOI: 10.1128/AAC.01653-08

RVK:

XA 24552

Language: English

Publisher: American Society for Microbiology

Publication Date: 2009

detail.hit.zdb_id: 1496156-8

SSG: 12

SSG: 15,3

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3

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Population pharmacokinetic analysis of abiraterone acetate in healthy volunteers and chemotherapy-naive and chemotherapy-pretreated metastatic castration-resistant prostate cancer patients.

Stuyckens, Kim ; Saad, Fred ; Xu, Steven ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2014

In: Journal of Clinical Oncology Vol. 32, No. 4_suppl ( 2014-02-01), p. 58-58

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 4_suppl ( 2014-02-01), p. 58-58

Abstract: 58 Background: Abiraterone acetate (AA) is an effective therapy for patients with metastatic castration-resistant prostate cancer (mCRPC). AA is metabolized to abiraterone, an androgen biosynthesis inhibitor. We performed population pharmacokinetic (PK) analyses to estimate PK parameters after a 1,000 mg/d oral dose of AA in patients with mCRPC with and without prior chemotherapy and after a one-time 1,000 mg dose in healthy volunteers, to determine consistency between groups. Methods: Studies included in analysis: COU-AA-302 (pre-chemotherapy mCRPC); COU-AA-301 and COU-AA-006 (post-docetaxel mCRPC); and COU-AA-008, COU-AA-009, and COU-AA-014 (healthy subjects). A total of 4,627 plasma concentrations from 360 subjects were analyzed using nonlinear mixed-effects modeling. Results: A two-compartment model with three-transit compartments following sequential zero-first order kinetics was used to characterize the systemic absorption of abiraterone. Absorption-related parameters were affected by food intake. Abiraterone PK was characterized by an extensive apparent clearance, which was lower in patients with mCRPC (1505 L/h) compared with healthy subjects (2240 L/h), and by large apparent central (5630 L) and peripheral volumes of distribution (17,400 L). PK of abiraterone was similar in chemotherapy-naïve and chemotherapy-pretreated patients and was characterized by a relatively high between- and within-subject variability (eg, between-subject coefficient of variation [CV%] for relative bioavailability in the clinical studies was 61.1% and the CV% for within-subject variability was 71.3%). No factors other than food intake and patient-healthy volunteer status impacted PK. Conclusions: Based on this population PK model, the recommended 1,000 mg/d dose of AA results in similar abiraterone exposure for patients with mCRPC regardless of prior chemotherapy status. The food effect on absorption-related parameters in this analysis confirms current dosing instructions for AA. Clinical trial information: NCT00638690, NCT00887198.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/jco.2014.32.4_suppl.58

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2014

detail.hit.zdb_id: 2005181-5

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4

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Model-Based Approach To Characterize Efavirenz Autoinduction and Concurrent Enzyme Induction with Carbamazepine

Zhu, Min ; Kaul, Sanjeev ; Nandy, Partha ; [et al.]

American Society for Microbiology ; 2009

In: Antimicrobial Agents and Chemotherapy Vol. 53, No. 6 ( 2009-06), p. 2346-2353

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In: Antimicrobial Agents and Chemotherapy, American Society for Microbiology, Vol. 53, No. 6 ( 2009-06), p. 2346-2353

Abstract: Characterization of the time course and magnitude of enzyme induction due to multiple inducers is important for interpretation of clinical data from drug-drug interaction studies. A population interaction model was developed to quantify efavirenz autoinduction and further induction with concurrent carbamazepine coadministration. Efavirenz concentration data in the absence and presence of carbamazepine following single- and multiple-dose oral administrations in healthy subjects were used for model development. The proposed model was able to describe the time-dependent efavirenz autoinduction and the further induction with carbamazepine when the agents were combined. The estimated population averages of efavirenz oral clearance were 5.5, 9.4, 14.4, and 16.7 liters/h on days 1, 14, and 35 and at steady state for the interaction, respectively, for efavirenz monotherapy for 2 weeks followed by the coadministration of carbamazepine for 3 weeks. The estimated times to 50% of the steady state for efavirenz autoinduction and for the induction resulting from the concurrent administration of efavirenz and carbamazepine were similar (around 10 to 12 days). With this model-based analysis, efavirenz exposures can be projected prior to and at the steady state of induction, allowing a better understanding of the time course and magnitude of enzyme induction.

Type of Medium: Online Resource

ISSN: 0066-4804 , 1098-6596

URL: Article

DOI: 10.1128/AAC.01120-08

RVK:

XA 24552

Language: English

Publisher: American Society for Microbiology

Publication Date: 2009

detail.hit.zdb_id: 1496156-8

SSG: 12

SSG: 15,3

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Pharmacokinetic-Pharmacodynamic-Model-Guided Doripenem Dosing in Critically Ill Patients

Samtani, Mahesh N. ; Flamm, Robert ; Kaniga, Koné ; [et al.]

American Society for Microbiology ; 2010

In: Antimicrobial Agents and Chemotherapy Vol. 54, No. 6 ( 2010-06), p. 2360-2364

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In: Antimicrobial Agents and Chemotherapy, American Society for Microbiology, Vol. 54, No. 6 ( 2010-06), p. 2360-2364

Abstract: The growing number of infections caused by multidrug-resistant pathogens has prompted a more rational use of available antibiotics given the paucity of new, effective agents. Monte Carlo simulations were utilized to determine the appropriateness of several doripenem dosing regimens based on the probability of attaining the critical drug exposure metric of time that drug concentrations remain above the drug MIC ( T 〉 MIC) for 35% (and lower thresholds) of the dosing interval in 〉 80 to 90% of the population ( T 〉 MIC 35% target). This exposure level generally correlates with in vivo efficacy for carbapenems. In patients with creatinine clearance of 〉 50 ml/min, a 500-mg dose of doripenem infused over 1 h every 8 h is expected to be effective against bacilli with doripenem MICs of ≤1 μg/ml based on a T 〉 MIC 35% target and MICs of ≤2 μg/ml based on lower targets. A longer, 4-hour infusion time improved target attainment in most cases, such that the T 〉 MIC was adequate for pathogens with doripenem MICs as high as 4 μg/ml. Efficacy is expected for infections caused by pathogens with doripenem MICs of ≤2 μg/ml in patients with moderate renal impairment (creatinine clearance, 30 to 50 ml/min) who receive doripenem at 250 mg infused over 1 h every 8 h and in patients with severe impairment (creatinine clearance between 10 and 29 ml/min) who receive doripenem at 250 mg, infused over 1 h or 4 h, every 12 h. Results of pharmacokinetics/pharmacodynamics (PK/PD) modeling can guide dose optimization, thereby potentially increasing the clinical efficacy of doripenem against serious Gram-negative bacterial infections.

Type of Medium: Online Resource

ISSN: 0066-4804 , 1098-6596

URL: Article

DOI: 10.1128/AAC.01843-09

RVK:

XA 24552

Language: English

Publisher: American Society for Microbiology

Publication Date: 2010

detail.hit.zdb_id: 1496156-8

SSG: 12

SSG: 15,3

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India’s external commercial borrowing: Pulled by domestic fundamentals or pushed by global conditions?

Sur, Abhisek ; Ray, Partha ; Nandy, Amarendu

Elsevier BV ; 2019

In: Journal of Asian Economics Vol. 61 ( 2019-04), p. 65-77

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In: Journal of Asian Economics, Elsevier BV, Vol. 61 ( 2019-04), p. 65-77

Type of Medium: Online Resource

ISSN: 1049-0078

URL: Article

DOI: 10.1016/j.asieco.2019.02.004

Language: English

Publisher: Elsevier BV

Publication Date: 2019

detail.hit.zdb_id: 2019933-8

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Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome

Zhang, Liping ; Yan, Xiaoyu ; Nandy, Partha ; [et al.]

SAGE Publications ; 2019

In: Therapeutic Advances in Cardiovascular Disease Vol. 13 ( 2019-01), p. 175394471986364-

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In: Therapeutic Advances in Cardiovascular Disease, SAGE Publications, Vol. 13 ( 2019-01), p. 175394471986364-

Abstract: This analysis aimed to evaluate the impact of rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome (ACS) and to determine whether therapeutic drug monitoring might provide additional information regarding rivaroxaban dose, beyond what patient characteristics provide. Methods: A post hoc exposure–response analysis was conducted using data from the phase III ATLAS ACS 2 Thrombolysis in Myocardial Infarction (TIMI) 51 study, in which 15,526 randomized ACS patients received rivaroxaban (2.5 mg or 5 mg twice daily) or placebo for a mean of 13 months (maximum follow up: 31 months). A multivariate Cox model was used to correlate individual predicted rivaroxaban exposures and patient characteristics with time-to-event clinical outcomes. Results: For the incidence of myocardial infarction (MI), ischemic stroke, or nonhemorrhagic cardiovascular death, hazard ratios (HRs) for steady-state maximum plasma concentration (C max ) in the 5th and 95th percentiles versus the median were statistically significant but close to 1 for both rivaroxaban doses. For TIMI major bleeding events, a statistically significant association was observed with C max [HR, 1.08; 95% CI, 1.06–1.11 (95th percentile versus median, 2.5 mg twice daily)], sex [HR, 0.56; 95% CI, 0.38–0.84 (female versus male)] , and previous revascularization [HR, 0.62; 95% CI, 0.44–0.87 (no versus yes)]. Conclusions: The shallow slopes of the exposure–response relationships and the lack of a clear therapeutic window render it unlikely that therapeutic drug monitoring in patients with ACS would provide additional information regarding rivaroxaban dose beyond that provided by patient characteristics.

Type of Medium: Online Resource

ISSN: 1753-9447 , 1753-9455

URL: Article

DOI: 10.1177/1753944719863641

Language: English

Publisher: SAGE Publications

Publication Date: 2019

detail.hit.zdb_id: 2387507-0

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Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate–Treated Castration-Resistant Prostate Cancer Patients

Xu, Xu S. ; Ryan, Charles J. ; Stuyckens, Kim ; [et al.]

American Association for Cancer Research (AACR) ; 2015

In: Clinical Cancer Research Vol. 21, No. 14 ( 2015-07-15), p. 3170-3177

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In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 21, No. 14 ( 2015-07-15), p. 3170-3177

Abstract: Purpose: We constructed a biomarker-survival modeling framework to explore the relationship between prostate-specific antigen (PSA) kinetics and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients following oral administration of 1,000 mg/day of abiraterone acetate (AA). Experimental Design: The PSA-survival modeling framework was based on data from two phase III studies, COU-AA-301 (chemotherapy pretreated, n = 1,184) and COU-AA-302 (chemotherapy naïve, n = 1,081), and included a mixed-effects tumor growth inhibition model and a Cox proportional hazards survival model. Results: The effect of AA on PSA kinetics was significant (P & lt; 0.0001) and comparable between the chemotherapy-naïve and -pretreated patients. PSA kinetics [e.g., PSA nadir, PSA response rate (≥30%, 50%, and 90%), time to PSA progression, PSA doubling time (PSADT)] were highly associated with OS in both populations. The model-based posttreatment PSADT had the strongest association with OS (HR ∼0.9 in both populations). The models could accurately predict survival outcomes. After adjusting for PSA kinetic endpoints, the treatment effect of AA on survival was no longer statistically significant in both studies, and the Prentice criteria of surrogacy were met for the PSA kinetic endpoints. A strong correlation was also observed between PSA and radiographic progression-free survival. Conclusions: The analysis revealed a consistent treatment effect of AA on PSA kinetics and strong associations between PSA kinetics and OS in chemotherapy-pretreated and -naïve patients, thereby providing a rationale to consider PSA kinetics as surrogacy endpoints to indicate clinical benefit in AA-treated patients with mCRPC regardless of chemotherapy treatment. Clin Cancer Res; 21(14); 3170–7. ©2015 AACR.

Type of Medium: Online Resource

ISSN: 1078-0432 , 1557-3265

URL: Article

DOI: 10.1158/1078-0432.CCR-14-1549

RVK:

XA 36791

Language: English

Publisher: American Association for Cancer Research (AACR)

Publication Date: 2015

detail.hit.zdb_id: 1225457-5

detail.hit.zdb_id: 2036787-9

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P1‐052: A SINGLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF THE ANTI‐PHOSPHO‐TAU ANTIBODY JNJ‐63733657 IN HEALTHY SUBJECTS

Galpern, Wendy R. ; Mercken, Marc ; Van Kolen, Kristof ; [et al.]

Wiley ; 2019

In: Alzheimer's & Dementia Vol. 15, No. 7S_Part_5 ( 2019-07)

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In: Alzheimer's & Dementia, Wiley, Vol. 15, No. 7S_Part_5 ( 2019-07)

Type of Medium: Online Resource

ISSN: 1552-5260 , 1552-5279

URL: Article

DOI: 10.1016/j.jalz.2019.06.077

Language: English

Publisher: Wiley

Publication Date: 2019

detail.hit.zdb_id: 2201940-6

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Population Pharmacokinetic Modeling of Tapentadol Extended Release (ER) in Healthy Subjects and Patients with Moderate or Severe Chronic Pain

Huntjens, Dymphy R. ; Liefaard, Lia C. ; Nandy, Partha ; [et al.]

Springer Science and Business Media LLC ; 2016

In: Clinical Drug Investigation Vol. 36, No. 3 ( 2016-3), p. 213-223

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In: Clinical Drug Investigation, Springer Science and Business Media LLC, Vol. 36, No. 3 ( 2016-3), p. 213-223

Type of Medium: Online Resource

ISSN: 1173-2563 , 1179-1918

URL: Article

DOI: 10.1007/s40261-015-0371-x

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2016

detail.hit.zdb_id: 2043793-6

SSG: 15,3

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Kooperativer Bibliotheksverbund

Berlin Brandenburg