Search Results - "Little, Thomas A."

Food Safety Exam Phrasing for Food Service Employees by Acosta, Karla M., Little, Thomas A., Khan, Ali, Yu, Heyao, Madera, Juan M., Sirsat, Sujata A.

“…•Exam phrasing positively impacted test−taking ability in the personal hygiene section.•No significant differences were seen in the basic food safety…”
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Corrigendum to “Analytical assessment of clonal derivation of eukaryotic/CHO cell populations” [J. Biotechnol. 286 (2018) 17–26] by Aebischer-Gumy, Christel, Moretti, Pierre, Little, Thomas A., Bertschinger, Martin

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Analytical assessment of clonal derivation of eukaryotic/CHO cell populations by Aebischer-Gumy, Christel, Moretti, Pierre, Little, Thomas A., Bertschinger, Martin

“…•TLA/NGS allowed identification of unique genetic features in two model cell lines.•A confidence interval for clonal derivation was determined by analysis of…”
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Persistence and Transfer of Enveloped Phi 6 Bacteriophage on Hotel Guest Room Surfaces by Mohammad, Zahra H, Little, Thomas A, Sirsat, Sujata A

“…The hotel guest room environment can be contaminated through touch or aerosols and become a source of viral transmission. Understanding the extent of…”
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Enveloped Phi 6 Bacteriophage Persistence and Cross-Contamination on the Surface of Farmers Market Fomites by Mohammad, Zahra H, Little, Thomas A, Sirsat, Sujata A

“…This study aimed to investigate the survival and persistence of enveloped phi 6 bacteriophages on several fomites at farmers markets and simulate…”
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Coronavirus Surrogate Persistence and Cross-Contamination on Food Service Operation Fomites by Mohammad, Zahra H, Little, Thomas A, Sirsat, Sujata A

“…This study investigated the persistence and transfer rate of phi 6 bacteriophage (SARS-CoV-2 surrogate) on food contact surfaces and fomites that are commonly…”
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Process and Method Variability Modeling to Achieve QbD Targets by Alasandro, Mark, Little, Thomas A.

“…A statistical modeling tool is presented that enables real-time viewing of how changes in method, process, and stability variability/bias impact product…”
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Application of the Quality‐by‐Design (QbD) Approach for Erythropoietin Alpha Purification by Kim, Tae Kyu, Seo, Kwang‐Seok, Kwon, Sang‐Oh, Little, Thomas A., Kim, Mijung, Kim, Chan‐Wha

“…This study was aimed at process characterization and improving quality of purification of erythropoietin α, a biopharmaceutical agent. In biopharmaceutical…”
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Applying the Quality by Design to Robust Optimization and Design Space Define for Erythropoietin Cell Culture Process by Kim, Tae Kyu, Seo, Kwang‐Seok, Kwon, Sang‐Oh, Kim, Hee‐Sung, Kim, Jun‐Hee, Jeong, Min‐Woo, Little, Thomas A., Kim, Mijung, Kim, Chan‐Wha

“…This study is aimed to identify the process characterization of the cell culture of the biopharmaceutical erythropoietin alpha. In biopharmaceutical…”
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Development of Cell-Based Relative Potency Assays for Antibody-Based Therapeutic Drug Products Against Botulism by Piazza, Timothy M., Geurs, Theresa L., Wolfe, Serena K., Harding, Daniel, Little, Thomas A., Tucker, Ward C.

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Method Validation Essentials, Limit of Blank, Limit of Detection, and Limit of Quantitation by Little, Thomas A

“…The following are several different types of assays, and the application of LOB, LOD, and LOQ to each type of method to determine the limits can be confusing…”
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Statistical Approaches for Determining Comparability of Biosimilars by Little, Thomas A

“…Biosimilars go through the same rigorous evaluation of safety and efficacy as any other biological drug product or drug substance. Because there is prior…”
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Essentials in Bioassay Development by Little, Thomas A

“…A bioassay measures biological activity or potency of a drug product (DP) or drug substance (DS), for which the most important critical quality attribute (CQA)…”
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Method validation essentials, limit of blank, limit of detection, and limit of quantitation: care needs to be made to match the method of limit determination to the analytical method by Little, Thomas A

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Identifying and Controlling CPPs and CMAs: Statistical methods to identify critical process parameters and critical material attributes--and approaches to control them--are needed to protect drug product and drug substances by Little, Thomas A

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Identifying and Controlling CPPs and CMAs by Little, Thomas A

“…Elements of drug development that may impact CQAs are as follows: * Excipient selection in formulation * Formulation concentrations * Formulation process for…”
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Establishing acceptance criteria for analytical methods: knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge by Little, Thomas A

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Essentials in Bioassay Design and Relative Potency Determination by Little, Thomas A

“…(ProQuest: ... denotes formulae omitted.) In defining bioassays and relative potency, the United States Pharmacopeia (USP) states (1): "Because of the inherent…”
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Essentials in Tolerance Design and Setting Specification Limits by Little, Thomas A

“…TOLERANCE INTERVAL APPROACH Tolerance intervals were developed to provide a correction for limited sample sizes and scales the interval of risk based on three…”
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Essentials in tolerance design and setting specification limits: specification limits should be set early in drug development and refined in later phases as data becomes available by Little, Thomas A

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