Publications by authors named "Shelby Anderson"

18 Publications

  • Page 1 of 1

Dietary ecology of Alaskan polar bears (Ursus maritimus) through time and in response to Arctic climate change.

Glob Chang Biol 2021 Apr 1. Epub 2021 Apr 1.

Department of Biological Sciences, Vanderbilt University, Nashville, TN, USA.

Arctic climate change poses serious threats to polar bears (Ursus maritimus) as reduced sea ice makes seal prey inaccessible and marine ecosystems undergo bottom-up reorganization. Polar bears' elongated skulls and reduced molar dentition, as compared to their sister species the grizzly bear (Ursus arctos), are adaptations associated with hunting seals on sea ice and a soft, lipid-rich diet of blubber and meat. With significant declines in sea ice, it is unclear if and how polar bears may be altering their diets. Clarifying polar bear dietary responses to changing climates, both today and in the past, is critical to proper conservation and management of this apex predator. This is particularly important when a dietary strategy may be maladaptive. Here, we test the hypothesis that hard-food consumption (i.e., less preferred foods including bone), inferred from dental microwear texture analysis, increased with Arctic warming. We find that polar bears demonstrate a conserved absence of hard-object feeding in Alaska through time (including approximately 1000 years ago), until the 21st century, consistent with a highly conserved and specialized diet of soft blubber and flesh. Notably, our results also suggest that some 21st-century polar bears may be consuming harder foods (e.g., increased carcass utilization, terrestrial foods including garbage), despite having skulls and metabolisms poorly suited for such a diet. Prior to the 21st century, only polar bears with larger mandibles demonstrated increased hard-object feeding, though to a much lower degree than closely related grizzly bears which regularly consume mechanically challenging foods. Polar bears, being morphologically specialized, have biomechanical constraints which may limit their ability to consume mechanically challenging diets, with dietary shifts occurring only under the most extreme scenarios. Collectively, the highly specialized diets and cranial morphology of polar bears may severely limit their ability to adapt to a warming Arctic.
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http://dx.doi.org/10.1111/gcb.15573DOI Listing
April 2021

Minimal impact of selective susceptibility reporting on the use of piperacillin-tazobactam for and bacteremia.

Infect Control Hosp Epidemiol 2021 Jan 11:1-3. Epub 2021 Jan 11.

University of Texas Southwestern Medical Center, Dallas, Texas.

Selective cascade reporting of antibiotic susceptibilities did not have a significant impact on de-escalation from piperacillin-tazobactam (PT), duration of PT use, length of stay, or rates of acute kidney injury and Clostridioides difficile infection in patients with positive monomicrobial blood cultures with either Escherichia coli or Klebsiella spp.
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http://dx.doi.org/10.1017/ice.2020.1385DOI Listing
January 2021

Minimal impact of selective susceptibility reporting on the use of piperacillin-tazobactam for and bacteremia.

Infect Control Hosp Epidemiol 2021 Jan 11:1-3. Epub 2021 Jan 11.

University of Texas Southwestern Medical Center, Dallas, Texas.

Selective cascade reporting of antibiotic susceptibilities did not have a significant impact on de-escalation from piperacillin-tazobactam (PT), duration of PT use, length of stay, or rates of acute kidney injury and Clostridioides difficile infection in patients with positive monomicrobial blood cultures with either Escherichia coli or Klebsiella spp.
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http://dx.doi.org/10.1017/ice.2020.1385DOI Listing
January 2021

Limited impact of selective susceptibility reporting of and isolates from concurrent blood and urine cultures.

Infect Control Hosp Epidemiol 2020 Jul 14:1-2. Epub 2020 Jul 14.

Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.

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http://dx.doi.org/10.1017/ice.2020.308DOI Listing
July 2020

Appropriateness of Fluoroquinolone Prescribing in the Long-Term Care Setting.

J Am Geriatr Soc 2020 03 10;68(3):661-663. Epub 2020 Jan 10.

Department of Pharmacy Practice, Texas Tech University Health Sciences Center School of Pharmacy, Dallas, Texas.

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http://dx.doi.org/10.1111/jgs.16324DOI Listing
March 2020

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

Standardizing the Use of Albumin in Large Volume Paracentesis.

J Pharm Pract 2020 Aug 6;33(4):420-424. Epub 2018 Dec 6.

Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.

Background: Albumin after large volume paracentesis (LVP) reduces paracentesis-induced circulatory dysfunction (PICD). The most efficacious dose of albumin for LVP is unclear.

Objective: To evaluate the impact of implementing a standardized LVP order set on albumin utilization and patient outcomes.

Methods: This is a retrospective review of patients with ascites due to cirrhosis who received a therapeutic paracentesis at a large, academic institution. Primary outcome was amount of albumin used prior to and after order set implementation. Albumin doses were standardized in the order set to 25 g (5-6 L removed), 50 g (7-10 L), and 75 g (>10 L). Patient outcomes were rates of hyponatremia, renal impairment, and hypotension.

Results: There were 100 patients included in each arm of the final analysis. Patients prior to order set implementation received a higher amount of albumin per liter removed compared to those post-implementation (8.3 g/L vs 6.5 g/L, respectively; < .01). There were no significant differences between groups in absolute changes in serum sodium (0 mEq/L vs -1 mEq/L, = .64), serum creatinine (0.06 mg/dL vs 0.05 mg/dL, = .94), or systolic blood pressure (-4 mm Hg vs -3 mm Hg, = .96). There were no differences between groups in rates of hyponatremia (1.6% vs 6.6%, = .21), renal impairment (11.3% vs 11.5%, = .97), or hypotension (17.4% vs 17.6%, = .97).

Conclusions: Use of an order set to guide albumin dosing based on amount of ascitic fluid removed during LVP resulted in a significant reduction in the amount of albumin given with no difference in adverse effects.
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http://dx.doi.org/10.1177/0897190018816252DOI Listing
August 2020

Assessment of the Biotransformation of Low-Turnover Drugs in the HREL Human Hepatocyte Coculture Model.

Drug Metab Dispos 2018 11 22;46(11):1617-1625. Epub 2018 Aug 22.

Q Solutions, a Quintiles Quest Joint Venture, Bioanalytical and ADME Laboratories, Indianapolis, Indiana

Metabolic profiles of four drugs possessing diverse metabolic pathways (timolol, meloxicam, linezolid, and XK469) were compared following incubations in both suspended cryopreserved human hepatocytes and the HREL hepatocyte coculture model. In general, minimal metabolism was observed following 4-hour incubations in both suspended hepatocytes and the HREL model, whereas incubations conducted up to 7 days in the HREL coculture model resulted in more robust metabolic turnover. In the case of timolol, in vivo human data suggest that 22% of the dose is transformed via multistep oxidative opening of the morpholine moiety. Only the first-step oxidation was detected in suspended hepatocytes, whereas the relevant downstream metabolites were produced in the HREL model. For meloxicam, both the hydroxymethyl and subsequent carboxylic acid metabolites were abundant following incubation in the HREL model, while only a trace amount of the hydroxymethyl metabolite was observed in suspension. Similar to timolol, linezolid generated substantially higher levels of morpholine ring-opened carboxylic acid metabolites in the HREL model. Finally, while the major aldehyde oxidase-mediated mono-oxidative metabolite of XK469 was minimally produced in hepatocyte suspension, the HREL model robustly produced this metabolite, consistent with a pathway reported to account for 54% of the total urinary excretion in human. In addition, low-level taurine and glycine conjugates were identified in the HREL model. In summary, continuous metabolite production was observed for up to 7 days of incubation in the HREL model, covering cytochrome P450, aldehyde oxidase, and numerous conjugative pathways, while predominant metabolites correlated with relevant metabolites reported in human in vivo studies.
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http://dx.doi.org/10.1124/dmd.118.082867DOI Listing
November 2018

Complement 3 Receptor Expression in Individuals with Type 2 Diabetes.

Recent Pat Antiinfect Drug Discov 2016 ;11(2):174-182

Microbiology/Immunology, Department of Basic Medical Sciences, College of Osteopathic Medicine of the Pacific, Western University of Health Sciences, 309 E Second Street, Pomona, CA 91766-1854. United States.

Background: According to the World Health Organization, as of 2014 9% of the world's adult population is affected by diabetes. Uncontrolled diabetes is a pro-inflammatory process that increases generation of reactive oxygen species (ROS).

Methods: The production of ROS leads to a chronic increase in oxidative stress which results in an increased susceptibility to infections. Individuals with type 2 diabetes mellitus (T2DM) are highly susceptible to Mycobacterium tuberculosis (M. tb) infection. Previous research has demonstrated that glutathione (GSH) plays an important role in the control of M. tb infection. Recent studies have demonstrated that phagocytosis of M.tb is diminished in patients with T2DM. Phagocytosis in macrophages is thought to be mediated in part by complement protein 3b (C3b)-complement protein receptor 3b (C3R) interactions. Since C3b production is not diminished in patients with T2DM we propose that C3R production is reduced and is the cause for impaired macrophage phagocytosis as well as IL-12 and IFN-γ signaling.

Conclusion: This study utilizes a quantitative PCR (qPCR), demonstrating decreased transcription of C3R mRNA in patients with T2DM as compared to non-diabetics.
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http://dx.doi.org/10.2174/1574891X11666160608121617DOI Listing
March 2017

Low-Turnover Drug Molecules: A Current Challenge for Drug Metabolism Scientists.

Drug Metab Dispos 2015 Dec 11;43(12):1917-28. Epub 2015 Sep 11.

Q Solutions, a Quintiles Quest Joint Venture, Bioanalytical and ADME Laboratories, Indianapolis, Indiana.

In vitro assays using liver subcellular fractions or suspended hepatocytes for characterizing the metabolism of drug candidates play an integral role in the optimization strategy employed by medicinal chemists. However, conventional in vitro assays have limitations in their ability to predict clearance and generate metabolites for low-turnover (slowly metabolized) drug molecules. Due to a rapid loss in the activity of the drug-metabolizing enzymes, in vitro incubations are typically performed for a maximum of 1 hour with liver microsomes to 4 hours with suspended hepatocytes. Such incubations are insufficient to generate a robust metabolic response for compounds that are slowly metabolized. Thus, the challenge of accurately estimating low human clearance with confidence has emerged to be among the top challenges that drug metabolism scientists are confronted with today. In response, investigators have evaluated novel methodologies to extend incubation times and more sufficiently measure metabolism of low-turnover drugs. These methods include plated human hepatocytes in monoculture, and a novel in vitro methodology using a relay of sequential incubations with suspended cryopreserved hepatocytes. In addition, more complex in vitro cellular models, such as HepatoPac (Hepregen, Medford, MA), a micropatterned hepatocyte-fibroblast coculture system, and the HµREL (Beverley Hills, CA) hepatic coculture system, have been developed and characterized that demonstrate prolonged enzyme activity. In this review, the advantages and disadvantages of each of these in vitro methodologies as it relates to the prediction of clearance and metabolite identification will be described in an effort to provide drug metabolism scientists with the most up-to-date experimental options for dealing with the complex issue of low-turnover drug candidates.
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http://dx.doi.org/10.1124/dmd.115.066431DOI Listing
December 2015

Synthesis of heterocyclic triads by Pd-catalyzed cross-couplings and evaluation of their cell-specific toxicity profile.

Org Lett 2014 Apr 18;16(7):2034-7. Epub 2014 Mar 18.

Department of Chemistry, University of Pittsburgh , Pittsburgh, Pennsylvania 15260, United States.

Two complementary approaches for the preparation of linked 5-membered heterocycles were developed. The Pd-catalyzed Suzuki-Miyaura cross-coupling with halogenated furan, thiophene, and selenophene led to higher overall yields, but C,H-bond activation was a more efficient strategy for the coupling at C(2) of oxazoles. Potency and selectivity of the final hydroxymethyl products in renal (A498), lung (NCI-H226), kidney (CAKI-1), and breast (MDA-MB-468, MCF7) carcinoma cell lines were determined.
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http://dx.doi.org/10.1021/ol500620mDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983320PMC
April 2014

Condensation reactions of guanidines with bis-electrophiles: Formation of highly nitrogenous heterocycles.

Tetrahedron 2013 Sep;69(36):7719-7731

University of Pittsburgh, Center for Chemical Methodologies and Library Development, Pittsburgh, PA 15260, USA.

2-Amino-1,4-dihydropyrimidines were reacted with bis-electrophiles to produce novel fused bi-pyrimidine, pyrimido-aminotriazine, and pyrimido-sulfonamide scaffolds. In addition, a quinazoline library was constructed using a guanidine Atwal-Biginelli reaction with 1-(quinazolin-2-yl)guanidines. The product heterocycles have novel constitutions with high nitrogen atom counts and represent valuable additions to screening libraries for the discovery of new modulators of biological targets.
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http://dx.doi.org/10.1016/j.tet.2013.04.127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3746774PMC
September 2013

Conference report: a hitchhiker's guide to outsourcing ADME studies: the inside of outsourcing.

Bioanalysis 2013 Feb;5(4):403-5

Celerion, Inc., Ebony, VA, USA.

This report gives a summary of the key points raised during a roundtable discussion convened at the American Association of Pharmaceutical Scientists 2012 Annual Meeting and Exposition held in Chicago on 17 October 2012. The science of ADME continues to grow, as does the impact of these studies on drug development. Understanding ADME requires efforts from several scientific specialties. With reductions in pharmaceutical company R&D staff there has been a corresponding growth in CROs with the capabilities and expertise to perform ADME work. This roundtable explored the challenges inherent in understanding ADME and the issues that arise when ADME studies shift from in-house study directors to external scientists working within the business model of a CRO. Pharmaceutical industry scientists and procurement specialists can satisfy their expectations by awareness of the growing expertise within CROs and the need for open communication among all partners involved in outsourced work.
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http://dx.doi.org/10.4155/bio.12.328DOI Listing
February 2013

Pharmacokinetics, metabolism, and excretion of the glycogen synthase kinase-3 inhibitor LY2090314 in rats, dogs, and humans: a case study in rapid clearance by extensive metabolism with low circulating metabolite exposure.

Drug Metab Dispos 2013 Apr 10;41(4):714-26. Epub 2013 Jan 10.

Drug Disposition/Pharmacokinetics/Pharmacodynamics, Lilly Research Laboratories,Indianapolis, Indiana, USA.

LY2090314 (3-[9-fluoro-2-(piperidin-1-ylcarbonyl)-1,2,3,4-tetrahydro[1,4]diazepino[6,7,1-hi]indol-7-yl]-4-imidazo[1,2-a]pyridin-3-yl-1H-pyrrole-2,5-dione) is an intravenous glycogen synthase kinase-3 inhibitor in oncology trials. Drug disposition was characterized after intravenous infusion of [(14)C]LY2090314 to rats and dogs, and was related to available clinical data. LY2090314 exhibited high clearance (approximating hepatic blood flow) and a moderate volume of distribution (∼1-2 l/kg) resulting in rapid elimination (half-life ∼0.4, 0.7, and 1.8-3.4 hours in rats, dogs, and humans, respectively). Scaled clearance from liver microsomes accurately predicted perfusion-limited clearance across species. LY2090314 was cleared by extensive metabolism, and the numerous metabolites were rapidly excreted into feces via bile (69-97% of dose; 62-93% within 0-24 hours); urinary recovery of drug-related material was low (≤3% of dose). Despite extensive metabolism, in rats and humans the parent compound was the sole identifiable drug-related moiety in plasma. Even in Mdr1a-, Bcrp-, and Mrp2-knockout rats, LY2090314 metabolites did not appear in circulation, and their urinary excretion was not enhanced, because the hypothesized impaired biliary excretion of metabolites in the absence of these canalicular transporters was not observed. Canine metabolite disposition was generally similar, with the notable exception of dog-unique LY2090314 glucuronide. This conjugate was formed in the dog liver and was preferentially excreted into the blood, where it accounted for the majority of circulating radioactivity at later times, and was predominantly recovered in urine (16% of dose). In conclusion, LY2090314 was rapidly cleared by extensive metabolism with negligible circulating metabolite exposures due to biliary excretion of metabolites into feces with no apparent intestinal reabsorption.
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http://dx.doi.org/10.1124/dmd.112.048488DOI Listing
April 2013

Effects of a novel mGlu₂/₃ receptor agonist prodrug, LY2140023 monohydrate, on central monoamine turnover as determined in human and rat cerebrospinal fluid.

Psychopharmacology (Berl) 2012 Feb 17;219(4):959-70. Epub 2011 Aug 17.

Lilly-NUS Centre for Clinical Pharmacology, Level 6 Clinical Research Centre (MD 11), National University of Singapore, 10 Medical Drive, Singapore 117597, Singapore.

Rationale: Accumulating evidence suggests that the primary symptoms of schizophrenia may be associated with altered central glutamate transmission. LY2140023 monohydrate is the methionine prodrug of the selective mGlu(2/3) receptor agonist LY404039 and is currently being assessed for the treatment of schizophrenia.

Objective: The objective of this study was to evaluate the central pharmacological activity of LY2140023 monohydrate in preclinical and clinical studies.

Methods: Effects on neurotransmitter/metabolite concentrations were assessed in male rats following single oral doses of LY2140023 monohydrate (microdiasylates from the prefrontal cortex), single intraperitoneal injection of LY404039 [cerebrospinal fluid (CSF)], or LY2140023 monohydrate dosed once daily for 7 days (CSF). A clinical study in 16 healthy subjects assessed the effects of LY2140023 monohydrate 40 mg orally twice daily for 14 days in lumbar CSF.

Results: Rat studies: Acute dosing with LY2140023 monohydrate resulted in significant dose-dependent increases in extracellular concentrations of dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA), but not 5-hydroxyindoleacetic acid (5-HIAA), in the prefrontal cortex. LY2140023 monohydrate dosing for 7 days elevated the concentrations of HVA in CSF, while acutely dosed LY404039 increased the concentrations of DOPAC, HVA, and methoxy-hydroxyphenylglycol (MHPG), but not 5-HIAA. Clinical study: Significant increases were seen for DOPAC, HVA, 5-HIAA, and MHPG in the CSF of subjects receiving LY2140023 monohydrate, but not placebo.

Conclusions: LY2140023 monohydrate and/or LY404039 dosing potently affected dopamine turnover and also significantly affected serotonin turnover in the human and rat central nervous systems. The measurement of biogenic amine metabolites such as DOPAC and HVA may serve as useful biomarkers of LY2140023 monohydrate and/or LY404039 central pharmacodynamic activity.
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http://dx.doi.org/10.1007/s00213-011-2427-9DOI Listing
February 2012

Overview of metabolite safety testing from an industry perspective.

Bioanalysis 2010 Jul;2(7):1249-61

Department of Drug Disposition, Lilly Research Laboratories, IN 46285, USA.

Regulatory guidelines on MIST were initially established in 2005 and finalized in 2008 by the US FDA and this has led to much discussion and debate on how to apply these recommendations in today's resource-constrained pharmaceutical environment. There are four aspects of MIST that impact on the field of bioanalysis: definition of a disproportionate human metabolite, establishment of nonclinical (animal) safety coverage for important human metabolites, degree of rigor in validation of bioanalytical methods to quantify metabolites when synthetic standards are available, and semiquantitation of metabolites when synthetic standards are not available. In this manuscript, each of these points has been addressed from a pharmaceutical industry standpoint, including a perspective on the necessary convergence of the fields of metabolite safety testing and bioanalysis.
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http://dx.doi.org/10.4155/bio.10.67DOI Listing
July 2010

Predicting circulating human metabolites: how good are we?

Chem Res Toxicol 2009 Feb;22(2):243-56

Department of Drug Disposition, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.

The FDA issued a guidance on the safety testing of metabolites in February 2008, in which they stated that metabolites of concern are those that are detected at levels greater than 10% of the systemic exposure of the parent at steady state. This has presented many challenges in determining the circulating human metabolites at an early stage of development. The intention of this perspective is to address the question of how effective in vitro metabolism and early exploratory clinical data are in predicting the circulating metabolites from both a qualitative and a quantitative perspective. To this end, data were reviewed from 17 molecules in the Lilly portfolio for which there were in vitro data and a radiolabeled study in humans. Twelve example cases are presented in detail to demonstrate trends for when in vitro data adequately predicted in vivo (41%), when in vitro data underpredicted the circulating metabolites (35%), and when in vitro data overpredicted the circulating metabolites (24%). In addition, cases that present special challenges due to very low levels of the circulating parent or long half-lives of the parent and/or metabolites are presented. The trends indicate that the more complex the metabolism, the less likely the in vitro data were to predict the circulating metabolites. The in vitro data were also less predictive for N-glucuronidations and non-P450-mediated cleavage reactions. Although the in vitro data were better at predicting clearance pathways, the data set often failed to predict the quantity of metabolites, which is needed in consideration of whether or not a "disproportionate" metabolite may be circulating in human plasma.
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http://dx.doi.org/10.1021/tx8004086DOI Listing
February 2009

Stereochemistry of 1,2-elimination reactions at the E2-E1cB interface--tert-butyl 3-tosyloxybutanoate and its thioester.

Org Biomol Chem 2008 May 14;6(9):1641-6. Epub 2008 Mar 14.

Department of Chemistry, Carleton College, Northfield, MN 55057, USA.

Experimental data on the stereoselectivity of base-catalyzed 1,2-elimination reactions that produce conjugated carbonyl compounds are scarce in spite of the importance of these reactions in organic and biochemistry. As part of a comprehensive study in this area, we have synthesized stereospecifically-deuterated beta-tosyloxybutanoate esters and thioesters and studied the stereoselectivity of their elimination reactions under non-ion pairing conditions. With the availability of both the (2R*,3R*) and (2R*,3S*) diastereomers the innate stereoselectivity could be determined unambiguously. (1)H and (2)H NMR data show that these substrates produce 5-6% syn elimination, the usual amount for acyclic substrates undergoing E2 reactions. Contrary to earlier suggestions, activation by a carbonyl group has virtually no influence upon the stereoselectivity. Elimination of the (2R*,3R*) diastereomer of the beta-tosyloxyester and thioester produces 21-25% of the (Z)-alkene, much more than observed with a poorer beta-nucleofuge. A relatively large amount of (Z)-alkene product seems to be a good marker for an E2 pathway, in which the transition state is E1cB-like, rather than an E1cB(irrev) mechanism. Syn KIE values were higher than those for anti elimination for the esters as well as the thioesters. Experimental challenges to the synthesis of stereospecifically-deuterated beta-tosyloxyesters are discussed.
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http://dx.doi.org/10.1039/b801592aDOI Listing
May 2008