Search Results - "Timko, Robert J"

Applying Quality by Design Concepts to Pharmacy Compounding by Timko, Robert J

“…Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug…”
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Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm by Van Buskirk, Glenn A., Asotra, Satish, Balducci, Christopher, Basu, Prabir, DiDonato, Gerald, Dorantes, Angelica, Eickhoff, W. Mark, Ghosh, Tapash, González, Mario A., Henry, Theresa, Howard, Matthew, Kamm, Jason, Laurenz, Steven, MacKenzie, Ryan, Mannion, Richard, Noonan, Patrick K., Ocheltree, Terrance, Pai, Umesh, Poska, Richard P., Putnam, Michael L., Raghavan, Ramani R., Ruegger, Colleen, Sánchez, Eric, Shah, Vinod P., Shao, Zezhi Jesse, Somma, Russell, Tammara, Vijay, Thombre, Avinash G., Thompson, Bruce, Timko, Robert J., Upadrashta, Satyam, Vaithiyalingam, Sivakumar

“…In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use…”
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Pharmaceutical compounding or pharmaceutical manufacturing? A regulatory perspective by Timko, Robert J, Crooker, Philip E M

“…At one time, nearly all prescriptions were compounded preparations. There is an ongoing demand for compounded prescription medications because manufacturers…”
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Sampling Results of the Improved SKC Diesel Particulate Matter Cassette by Noll, James D., Timko, Robert J., McWilliams, Linda, Hall, Peter, Haney, Robert

“…Diesel particulate matter (DPM) samples from underground metal/nonmetal mines are collected on quartz fiber filters and measured for carbon content using…”
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Methods to lower the dust exposure of bag machine operators and bag stackers by Cecala, A B, Timko, R J, Thimons, E D

“…This article reviews various dust control technologies developed over the years at the Pittsburgh Research Laboratory of the National Institute for…”
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The effect of thermal history on the transition temperature of citric acid glass by Timko, R J, Lordi, N G

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Differential pressure response of 25-mm-diameter glass fiber filters challenged with coal and limestone dust mixtures by Dobroski, Jr, Harry, Tuchman, Donald P, Vinson, Robert P, Timko, Robert J

“…This article summarizes results of research conducted by the National Institute for Occupational Safety and Health (NIOSH) at its Pittsburgh Research…”
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Thermal characterization of citric acid solid dispersions with benzoic acid and phenobarbital by Timko, R J, Lordi, N G

“…The glass transition temperatures of citric temperatures of citric acid glass were determined by differential scanning calorimetry to be 10.2 and 13.5 degrees…”
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In vitro evaluation of three commercial sustained-release papaverine hydrochloride products by Timko, R J, Lordi, N G

“…Three commercial sustained-release papaverine hydrochloride products in the form of microencapsulated pellets were evaluated. Three different dissolution…”
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Drug substance starting material selection: a science- and risk-based approach by Illing, Graham T, Timko, Robert J, Billett, Linda

“…The authors review the current regulatory framework for the selection of drug substance starting materials. In addition, a proposal is discussed for a science-…”
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