Search Results - "Novick, Steven J."
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A comparison of statistical methods for animal oncology studies
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01-01-2023)“…In pre‐clinical oncology studies, tumor‐bearing animals are treated and observed over a period of time in order to measure and compare the efficacy of one or…”
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2
A simple test for synergy for a small number of combinations
Published in Statistics in medicine (20-12-2013)“…A method for detecting deviations from the Loewe additive drug combination reference model for in vitro drug combination experimentation is described. It is…”
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3
Pharmacovirological Impact of an Integrase Inhibitor on Human Immunodeficiency Virus Type 1 cDNA Species In Vivo
Published in Journal of Virology (01-08-2009)“…Article Usage Stats Services JVI Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley…”
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4
Setting Alert and Action Limits in the Presence of Significant Amount of Censoring in Data
Published in PDA journal of pharmaceutical science and technology (01-01-2017)“…In manufacturing settings, control limits are often set using a three-sigma rule (i.e., three estimated standard deviations above and below the estimated…”
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5
Pharmacokinetics/Pharmacodynamics of Peptide Deformylase Inhibitor GSK1322322 against Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus in Rodent Models of Infection
Published in Antimicrobial agents and chemotherapy (01-01-2016)“…GSK1322322 is a novel inhibitor of peptide deformylase (PDF) with good in vitro activity against bacteria associated with community-acquired pneumonia and skin…”
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6
A new PK equivalence test for a bridging study
Published in Journal of biopharmaceutical statistics (02-09-2016)“…In a bridging study, the plasma drug concentration-time curve is generally used to assess bioequivalence between the two formulations. Selected pharmacokinetic…”
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7
Directly testing the linearity assumption for assay validation
Published in Journal of chemometrics (01-05-2013)“…The ICH Q2(R1) (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guideline for testing…”
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8
Development of a high-throughput electrophysiological assay for the human ether-à-go-go related potassium channel hERG
Published in Journal of pharmacological and toxicological methods (01-01-2013)“…Drug-induced prolongation of the QT interval via block of the hERG potassium channel is a major cause of attrition in drug development. The advent of automated…”
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Testing Assay Linearity Over a Pre-Specified Range
Published in Journal of biopharmaceutical statistics (04-03-2015)“…Validation of linearity is a regulatory requirement. Although many methods are proposed, they suffer from several deficiencies including difficulties of…”
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10
The acute extracellular flux (XF) assay to assess compound effects on mitochondrial function
Published in Journal of biomolecular screening (01-03-2015)“…Numerous investigations have linked mitochondrial dysfunction to adverse health outcomes and drug-induced toxicity. The pharmaceutical industry is challenged…”
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11
Testing drug additivity based on monotherapies
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (01-07-2015)“…Under the Loewe additivity, constant relative potency between two drugs is a sufficient condition for the two drugs to be additive. Implicit in this condition…”
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12
Nonlinear Blending: A Useful General Concept for the Assessment of Combination Drug Synergy
Published in Journal of receptors and signal transduction (01-01-2007)“…Human diseases may involve cellular signaling networks that contain redundant pathways, so that blocking a single pathway in the system cannot achieve the…”
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13
Corrected Score Estimation via Complex Variable Simulation Extrapolation
Published in Journal of the American Statistical Association (01-06-2002)“…A Monte Carlo method of computing unbiased estimating equations for the analysis of data measured with error is described. Asymptotic distribution results are…”
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14
Estimating a nonlinear function of a normal mean
Published in Biometrika (01-09-2005)“…We derive a Monte-Carlo-amenable, minimum variance unbiased estimator of a nonlinear function of a normal mean and the variance of the estimator. Applications…”
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15
Development and Validation of a high-throughput Structure-Activity Relationship Assay for the hERG Potassium Channel
Published in Biophysical journal (31-01-2012)Get full text
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