Publications by authors named "Jennifer Vance"

16 Publications

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Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.

Bioanalysis 2021 Apr 13;13(8):609-619. Epub 2021 Apr 13.

Worldwide Clinical Trials, Austin, TX, USA.

The 13th Global CRO Council (GCC) closed forum for bioanalysis was held in New Orleans, LA, USA on 5 April 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. While ICH M10 will cover requirements for reference standards, one of the biggest challenges facing the CRO community is the lack of consistency and completeness of Certificates of Analysis for reference standards used in regulated bioanalysis. Similar challenges exist with critical reagents (e.g., capture and detection antibodies) used for assays supporting biologics. The recommendations provided in this publication are the minimum requirements for the content that GCC members believe should be included in Certificates of Analysis for reference standards obtained from commercial vendors, sponsors and compendial suppliers, for use in regulated bioanalytical studies. In addition, recommendations for internal standards, metabolites and critical reagents are discussed.
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http://dx.doi.org/10.4155/bio-2021-0046DOI Listing
April 2021

GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.

Bioanalysis 2019 Sep 30;11(18s):1-228. Epub 2019 Sep 30.

WuXi Apptec, Shanghai, China.

The 13 GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.
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http://dx.doi.org/10.4155/bio-2019-0207DOI Listing
September 2019

Modules for the Technical Skills Section of the OSCE Component of the American Board of Anesthesiology APPLIED Examination.

MedEdPORTAL 2019 04 29;15:10820. Epub 2019 Apr 29.

Professor, Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center.

Introduction: To assess communication and professionalism, as well as technical skills related to patient care, the American Board of Anesthesiology (ABA) has begun administering an Objective Structured Clinical Examination (OSCE) portion of the APPLIED Examination in addition to the Standard Oral Examination component.

Methods: We created video modules and a curriculum for anesthesiology resident OSCE preparation for the Interpretation of Monitors and Interpretation of Echocardiography components. The modules can be used individually by trainees or included as part of an OSCE workshop led by faculty educators with seven individual stations matching the content of the actual ABA examination. These modules are recommended for all levels of anesthesiology trainees so that they can gain exposure to the format and the fast pace of the examination.

Results: Sixty-six junior and senior anesthesiology residents, fellows, and junior faculty successfully participated in these modules. Seventy-three percent of the participants agreed that after completing these modules, they now had a good understanding of the Interpretation of Monitors and Interpretation of Echocardiography technical skills stations. More than 90% of participants reported that the modules were useful, and more than 70% reported that they now felt prepared for these stations of the OSCE.

Discussion: Developing technical skills stations for deliberate practice and preparation for the ABA OSCE is resource intensive. Finding time and faculty to facilitate OSCE preparation is also challenging. With the video modules and scripts included in this publication, residents can practice independently or as part of larger preparation course.
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http://dx.doi.org/10.15766/mep_2374-8265.10820DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6507923PMC
April 2019

Quantitation of free and total N-acetylcysteine amide and its metabolite N-acetylcysteine in human plasma using derivatization and electrospray LC-MS/MS.

J Chromatogr B Analyt Technol Biomed Life Sci 2019 Mar 23;1109:25-36. Epub 2019 Jan 23.

AIT Bioscience, LLC, 7840 Innovation Blvd, Indianapolis, IN 46278, USA. Electronic address:

Studies of N-acetylcysteine amide (NACA) in nonclinical models have demonstrated various antioxidant, anti-apoptotic, anti-inflammatory and neuroprotective effects, and it is currently being developed as a treatment for retinitis pigmentosa. Sensitive LC-MS/MS methods were developed and validated to quantitate reduced and total NACA and its major metabolite, N-acetylcysteine (NAC), in human plasma to support clinical studies involving NACA. To trap and stabilize reduced NACA and NAC at the time of collection, whole blood was immediately treated with 2-chloro-1-methylpyridinium iodide (CMPI) to convert free thiols to 1-methylpyridinyl thioether derivatives. Plasma was harvested and frozen until samples were assayed using protein precipitation and an LC-MS/MS separation based on hydrophilic-interaction chromatography (HILIC). To process NACA and NAC present as disulfides, an intermediate portion of the extract was further subjected to reduction with tris(2-carboxyethyl) phosphine; the released thiols were then reacted with CMPI, extracted, and analyzed as before, to measure total thiols. The method for NACA and NAC, whether free/reduced or total, covered a range from 50 ng/mL to 50 μg/mL in human plasma and required a single 25 μL plasma sample. Up to 180 samples could be assayed in a single session. The inter-run mean bias and precision (%CV) were within ±5% for the free thiol method and within ±8.5% for the total thiol method. Benchtop, freeze/thaw, and long-term stability were evaluated and acceptable. The NAC/NACA method applied to a clinical study demonstrated incurred sample reproducibility of 95.5% for NAC and 99.1% for NACA.
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http://dx.doi.org/10.1016/j.jchromb.2019.01.013DOI Listing
March 2019

Pleural Effusion Causing Cardiac Tamponade Following the Transition From Negative- to Positive-Pressure Ventilation During Aortic Aneurysm Repair.

J Cardiothorac Vasc Anesth 2016 Jun 1;30(3):736-40. Epub 2015 Sep 1.

University of Michigan Medical School, Ann Arbor, MI.. Electronic address:

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http://dx.doi.org/10.1053/j.jvca.2015.08.034DOI Listing
June 2016

Intraoperative bispectral index monitoring and time to extubation after cardiac surgery: secondary analysis of a randomized controlled trial.

BMC Anesthesiol 2014 18;14:79. Epub 2014 Sep 18.

Department of Anesthesiology, University of Michigan Medical School, 1H247 UH Box 5048, 1500 East Medical Center Drive, Ann Arbor, MI 48109, USA.

Background: Fast track recovery is a care process goal after cardiac surgery. Intraoperative anesthetic depth may impact recovery, but the impact of brain monitoring on time to extubation and intensive care unit (ICU) length of stay after cardiac surgery has not been extensively studied. Our goal was to determine if BIS-guided anesthesia improves time to extubation compared to MAC-guided anesthesia in a cardiac surgery population.

Methods: In this secondary outcome analysis of a randomized controlled study, we analyzed 294 patients undergoing elective coronary bypass grafting, valve replacements, and bypass plus valve replacements at a single tertiary referral center between February 1, 2009 and April 30, 2010. We analyzed cardiac surgery patients that had been randomized to BIS-guided anesthesia alerts (n = 131) or MAC-guided anesthesia alerts (n = 163). The primary outcome measure was time to extubation in the BIS-guided and anesthetic concentration-guided groups. Secondary outcomes were length of stay in the ICU and total postoperative hospital length of stay.

Results: Valid extubation time data were available for 247 of 294 patients. The median [IQR] time to extubation was 307 [215 to 771] minutes in the BIS group and 323 [196 to 730] minutes in the anesthetic concentration group (p = 0.61). The median [IQR] ICU length of stay was 54 [29 to 97] hours versus 70 [44 to 99] hours (p = 0.11). In terms of postoperative hospital length of stay, there was no difference between the groups with median [IQR] times of 6 [5-8] days (p = 0.69) in each group.

Conclusions: The use of intraoperative BIS monitoring during cardiac surgery did not change time to extubation, ICU length of stay or hospital length of stay. Data regarding BIS monitoring and recovery in an exclusively cardiac surgery population are consistent with recent effectiveness studies in the general surgical population.

Trial Registration: ClinicalTrials.gov number NCT00689091.
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http://dx.doi.org/10.1186/1471-2253-14-79DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4172314PMC
April 2015

Reply: To PMID 24206967.

Ann Thorac Surg 2014 Aug;98(2):782-3

Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI.

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http://dx.doi.org/10.1016/j.athoracsur.2014.05.014DOI Listing
August 2014

The independent effects of anemia and transfusion on mortality after coronary artery bypass.

Ann Thorac Surg 2014 Feb 6;97(2):514-20. Epub 2013 Nov 6.

Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.

Background: Both anemia and transfusions (Tx) are associated with mortality after cardiac operations. However, the relative contributions of anemia and Tx and their interaction on late mortality have not been determined.

Methods: 922 patients who underwent isolated coronary artery bypass grafting (CABG) were retrospectively studied. Anemia (A+) was defined as hemoglobin<12 g/dL for men and <11 g/dL for women. Patients who received (Tx+) and did not receive (Tx-) transfusions were compared; patient characteristics were controlled for by the use of Cox analysis and then by matching Tx+ to Tx- patients based on identical hemoglobin levels at admission and by propensity matching.

Results: 5.3% of Tx- patients died, compared with 11% of Tx+ patients (p=0.001). The interaction of anemia and Tx was associated with a greater hazard of dying. In particular, A+Tx+ (anemic, received transfusion) patients had a threefold hazard of death (2.918, 95% confidence interval=1.512-5.633, p=0.001) compared with A-Tx- (nonanemic, no transfusion) patients. A+Tx+ patients had twice the hazard of dying as did A+Tx- (anemic, no transfusion) (hazard ratio=2.087, 95% confidence interval=1.004-4.336, p=0.049). In populations matched by preoperative hemoglobin levels or by propensity scores, similar results were seen: a significant interaction between anemia and transfusion of red blood cells. A+Tx+ patients fared significantly worse than did the other three groups. Although there was no difference in mortality between A- patients who did or did not receive transfusions, A+T+ patients had triple the risk as A+T- patients, whereas A+Tx- patients had a similar risk of late mortality as A-Tx- patients.

Conclusions: The anemia-transfusion interaction was associated with an increased hazard of late mortality.
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http://dx.doi.org/10.1016/j.athoracsur.2013.09.019DOI Listing
February 2014

Interpretation of elevated transvalvular pressure gradients across a tilting-disc mitral valve in the setting of severe aortic insufficiency.

J Cardiothorac Vasc Anesth 2012 Oct 5;26(5):966-7. Epub 2012 Jun 5.

Cardiovascular Center, Division of Cardiac Anesthesiology, University of Michigan, Ann Arbor, MI 48109, USA.

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http://dx.doi.org/10.1053/j.jvca.2012.04.011DOI Listing
October 2012

Cardiothoracic anesthesiology fellowship: challenges of training and a novel approach to resident education.

J Cardiothorac Vasc Anesth 2011 Dec 14;25(6):1204-6. Epub 2011 Oct 14.

Department of Anesthesiology, Cardiovascular Center, University of Michigan Health Systems, Ann Arbor, MI.

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http://dx.doi.org/10.1053/j.jvca.2011.08.016DOI Listing
December 2011

Lithography of Polymer Nanostructures on Glass for Teaching Polymer Chemistry and Physics.

J Chem Educ 2011 May;88(5):615-618

Department of Chemistry and Biochemistry, Hunter College of the City University of New York, New York, New York 10065, United States.

As nanolithography becomes increasingly important in technology and daily life, a variety of inexpensive and creative methods toward communicating the concepts underpinning these processes in the classroom are necessary. An experiment is described that uses simple CD-Rs, C-clamps, an oven, and a freezer to provide concrete examples and insights into the chemistry and principles of nanolithography. The experiment also has flexibility, making it suitable for a range of classroom levels from high school to more advanced labs in college. Because CD-Rs are composed of grooves of polycarbonate, the experiment provides a basis for discussions and exploration into the chemistry and physics of polymers on the nanoscale.
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http://dx.doi.org/10.1021/ed100358nDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3115560PMC
May 2011

Cyclic 1,2-diketones as core building blocks: a strategy for the total synthesis of (-)-terpestacin.

Chemistry 2010 Jun;16(21):6265-77

Department of Chemistry, Stanford University, Stanford, California 94305-5080, USA.

We report a full account of our work towards the total synthesis of (-)-terpestacin (1), a sesterterpene originally isolated from fungal strain Arthrinium sp. FA1744. Its promising anti-HIV and anti-cancer activity, as well as its novel structure, make terpestacin an attractive synthetic target. A strategy based on the unique reactivity of cyclic 1,2-diketones (diosphenols) was developed and total synthesis of 1 was achieved in 20 steps, in the longest linear sequence, from commercially available 2-hydroxy-3-methyl-2-cyclopenten-1-one. The key feature of our synthesis is the double usage of a "Pd AAA-Claisen" protocol (AAA=asymmetric allylic alkylation), first in the early stages to generate the C1 quaternary center and then in the late stages to install the side chain. In addition, a rather unusual ene-1,2-dione moiety was synthesized and utilized as an excellent Michael acceptor to attach the C15 substituent. Several possible routes towards the total synthesis have been examined and carefully evaluated. During our exploration many interesting chemoselectivity issues have been addressed, such as a highly selective ring-closing metathesis and a challenging oxidation of a disubstituted olefin in the presence of three trisubstituted ones.
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http://dx.doi.org/10.1002/chem.200903356DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2914478PMC
June 2010

Imidazolylsulfonates: electrophilic partners in cross-coupling reactions.

Org Lett 2009 Apr;11(7):1463-6

Synthetic Chemistry, Chemical & Physical Sciences, Schering-Plough Corporation, 1011 Morris Avenue, Union, New Jersey 07083, USA.

Aryl imidazolylsulfonates participate as electrophilic coupling partners in palladium-mediated cross-coupling reactions. The aryl imidazolylsulfonates display good stability while maintaining good reactivity in a variety of palladium-catalyzed coupling reactions. Imidazolylsulfonates are a practical and economic alternative to triflates.
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http://dx.doi.org/10.1021/ol802381kDOI Listing
April 2009

Imidazolylsulfonates: electrophilic partners in cross-coupling reactions.

Org Lett 2009 Apr;11(7):1463-6

Synthetic Chemistry, Chemical & Physical Sciences, Schering-Plough Corporation, 1011 Morris Avenue, Union, New Jersey 07083, USA.

Aryl imidazolylsulfonates participate as electrophilic coupling partners in palladium-mediated cross-coupling reactions. The aryl imidazolylsulfonates display good stability while maintaining good reactivity in a variety of palladium-catalyzed coupling reactions. Imidazolylsulfonates are a practical and economic alternative to triflates.
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http://dx.doi.org/10.1021/ol802381kDOI Listing
April 2009

A diosphenol-based strategy for the total synthesis of (-)-terpestacin.

J Am Chem Soc 2007 Apr 8;129(15):4540-1. Epub 2007 Mar 8.

Department of Chemistry, Stanford University, Stanford, CA 94305-5080, USA.

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http://dx.doi.org/10.1021/ja070571sDOI Listing
April 2007

Synthesis and evaluation of aminomethyl dihydrocinnamates as a new class of PPAR ligands.

Bioorg Med Chem Lett 2006 Dec 26;16(24):6328-33. Epub 2006 Sep 26.

Eli Lilly and Co, Indianapolis, IN 46285, USA.

PPAR ligands with varied subtype selectivity have been synthesized using an achiral aminomethyl dihydrocinnamate template. Several compounds in this series have demonstrated potent plasma glucose and triglyceride lowering capability in rodent models of type 2 diabetes.
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http://dx.doi.org/10.1016/j.bmcl.2006.09.011DOI Listing
December 2006