Publications by authors named "Marie Rock"

8 Publications

  • Page 1 of 1

Preadmission predictors for first semester course success in a baccalaureate nursing program.

J Prof Nurs 2020 Sep - Oct;36(5):322-329. Epub 2020 Feb 1.

Department of Nursing, Towson University, Towson, MD, United States of America.

Background: Identifying students' who are able to complete a rigorous course of study, graduate on time, and pass the NCLEX-RN© is a principle role of nursing program admissions teams.

Purpose: To examine which preadmission factors predict students' success in the first semester of a baccalaureate nursing program.

Methods: Undergraduate students' data from the academic years 2013 to 2017 were analyzed (N = 927). Bivariate and multiple regression analyses were used to examine potential predictors of first semester course success, and scores on standardized NCLEX preparation exams.

Results: Preadmission cumulative GPA (OR = 3.82, 95% CI = 1.43-10.16) and prerequisite science GPA (OR = 2.57, 95% CI = 1.14-5.78) predicted success in the pathopharmacology course. Preadmission cumulative GPA (OR = 6.53, 95% CI = 1.59-26.85) and TEAS composite score (OR = 1.15, 95% CI = 1.09-1.22) predicted success in the health assessment course. Preadmission cumulative GPA (OR = 3.42, 95% CI = 1.18-9.92) and TEAS composite score (OR = 1.05, 95% CI = 1.01-1.10) predicted success in the foundations course. Higher preadmission cumulative GPA (B = 14.19, p < 0.01), prerequisite science GPA (B = 12.62, p < 0.01), and TEAS composite score (B = 0.48, p < 0.01) predicted a higher pathopharmacology-KAPLAN, Inc. test scores. Higher preadmission cumulative GPA (B = 62.52, p < 0.01), prerequisite science GPA (B = 61.18, p < 0.01), and TEAS composite score (B = 4.76, p < 0.01) predicted a higher fundamentals-HESI test scores.

Conclusions: Preadmission cumulative GPA, prerequisite science GPA, and TEAS composite score were significant predictors of success in first semester courses and performance on standardized tests.
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http://dx.doi.org/10.1016/j.profnurs.2020.01.007DOI Listing
February 2020

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.

AAPS J 2015 Jul 30;17(4):1019-24. Epub 2015 Apr 30.

MKelley Consulting LLC, West Chester, PA, USA.

A novel format was introduced at the recent AAPS NBC Workshop on Method Development, Validation and Troubleshooting in San Diego on 18th May 2014. The workshop format was initiated by Binodh De Silva; Marie Rock and Sherri Dudal joined the initiative to develop and chair the workshop. Questions were solicited by a variety of avenues, including a Linked-In Discussion Group. Once collated and clarified, the topics covered assay development, validation, and analysis of PK, Immunogenicity, and Biomarkers with an additional topic on alternative bioanalytical technologies. A panel of experts (workshop report co-authors) was assigned to each topic to bring forward thought-provoking aspects of each topic. The format of the workshop was developed to target the needs of bioanalytical scientists with intermediate to advanced experience in the field ranging to enable robust discussion and to delve deeper into the current bioanalytical hot topics. While the new format allowed for an interactive session with the topical discussion driven by the audience members, it did not foster equal discussion time for all of the proposed topics, especially Biomarkers and alternative LBA technologies.
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http://dx.doi.org/10.1208/s12248-015-9767-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4476978PMC
July 2015

Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.

AAPS J 2015 Mar 31;17(2):277-88. Epub 2014 Dec 31.

U.S. Food and Drug Administration, Silver Spring, MD, USA.

In September 2013, the FDA released a draft revision of the Bioanalytical Method Validation (BMV) Guidance, which included a number of changes to the expectations for bioanalysis, most notably the inclusion of biomarker assays and data. To provide a forum for an open, inclusive discussion of the revised draft BMV Guidance, the AAPS and FDA once again collaborated to convene a two-and-a-half day workshop during early December 2013 in Baltimore, MD, USA. The resulting format embodied extensive open discussion and each thematic session included only brief, concise descriptions by Agency and industry representatives prior to opening the floor discussion. The Workshop was built around four thematic sessions (Common Topics, Chromatographic, Ligand-Binding Assays, and Biomarkers) and a final session with international regulators, concluding with a review of the outcomes and recommendations from the thematic sessions. This Workshop report summarizes the outcomes and includes topics of agreement, those where the FDA will consider the Industry's perspective, and those where the workshop provided a first open dialogue. This article will be available to the bioanalytical community at http://www.aaps.org/BMV13 .
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http://dx.doi.org/10.1208/s12248-014-9696-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365089PMC
March 2015

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Bioanalysis 2012 Sep;4(17):2117-26

Advion Bioanalytical Laboratories, Quintiles, NY, USA.

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.
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http://dx.doi.org/10.4155/bio.12.192DOI Listing
September 2012

Development and validation of novel enzyme activity methods to assess inhibition of matrix metalloproteinases (MMPs) in human serum by antibodies against enzyme therapeutics.

J Pharm Biomed Anal 2012 Nov 28;70:408-14. Epub 2012 Jun 28.

Consultant to Auxilium, Edkins Pharma Services, LLC, Wayne, PA 19087-3229, USA.

This paper summarizes the development and validation of five enzyme activity methods to assess the specific inhibition of human endogenous matrix metalloproteinases MMP-1 (interstitial collagenase), MMP-2 (gelatinase A), MMP-3 (stromelysin 1), MMP-8 (collagenase 2) and MMP-13 (collagenase 3) by anti-Collagenase Clostridium histolyticum (CCH) antibodies in human serum. These MMPs are of interest since antibodies against a therapeutic enzyme may cross-react with, and inactivate, the MMPs. The validated methods utilize spiked exogenous individual MMPs added to serum to determine if the serum inhibits MMP enzyme activity. Factors evaluated and optimized during development include pH, reaction time and temperature, inhibitor concentration for the positive control, and substrate and serum concentration. Characteristics established during validation for each MMP activity inhibition method included intra- and inter-assay precision and recovery, recovery in the pooled normal human serum samples, bench-top stability at room temperature and on wet ice, and assay cut-point determination. Precision results ranged from ~1 to 12% CV, recoveries of the activities of the exogenous MMPs ranged from ~84 to 90% and cut-point values ranged from 67 to 91%.
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http://dx.doi.org/10.1016/j.jpba.2012.06.012DOI Listing
November 2012

Determination of granulocyte colony stimulating factor and its antibody in human serum samples using the BIAcore 3000 biosensor.

Anal Biochem 2004 Jan;324(2):304-6

Global Drug Metabolism, Pharmacia Corporation, 4901 Searle Parkway, Skokie, IL 60077, USA.

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http://dx.doi.org/10.1016/j.ab.2003.09.034DOI Listing
January 2004

Use of optical biosensor technology to study immunological cross-reactivity between different sulfonamide drugs.

Anal Biochem 2002 Jan;300(2):177-84

Global Drug Metabolism, Pharmacia Corporation, 4901 Searle Parkway, Skokie, Illinois 60077, USA.

Adverse reactions to medications account for a substantial number of hospitalizations and in some cases fatalities. The nature of the many drug-drug interactions caused by the inhibition of drug-metabolizing enzymes can now be predicted and examined with a greater deal of accuracy due to research developments in the understanding of the drug-metabolizing enzymes. However, the more troubling aspects of drug-drug interactions are the idiosyncratic reactions that are unpredictable and quite often life-threatening. These reactions are often caused by a prior sensitization of a person's immune system to a given drug or class of drugs. The following work offers a technique to examine in a medium-throughput system the cross-reactivity of drugs to antibodies in order to predict if structures share the same antigenic potential toward a sensitized individual. Two commercially important sulfonamide drugs, sulfamethazine and furosemide, were taken and their binding to their respective antibodies were tested in the presence of other structurally related sulfonamide drugs. The BIACORE 3000 biosensor was used for the study and the solution-phase equilibrium assay principle was employed. The data obtained help us determine which drugs can react, and to what extent, with sulfamethazine and furosemide, giving rise to possible allergic or hypersensitivity reactions. Though sulfamethazine and furosemide were used in this study; this principle and methodology can be applied to study any drug molecule-antibody pair.
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http://dx.doi.org/10.1006/abio.2001.5467DOI Listing
January 2002