Search Results - "Ulman, Katherine"

Elemental Impurities in Pharmaceutical Excipients by Li, Gang, Schoneker, Dave, Ulman, Katherine L, Sturm, Jason J, Thackery, Lisa M, Kauffman, John F

“…Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug…”
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Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles by Van Buskirk, Glenn A., Arsulowicz, Daniel, Basu, Prabir, Block, Lawrence, Cai, Bing, Cleary, Gary W., Ghosh, Tapash, González, Mario A., Kanios, David, Marques, Margareth, Noonan, Patrick K., Ocheltree, Terrance, Schwarz, Peter, Shah, Vinod, Spencer, Thomas S., Tavares, Lino, Ulman, Katherine, Uppoor, Rajendra, Yeoh, Thean

“…In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery…”
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Mitigating the Risk from Excipient Variability by Carlin, Brian, Collins, George, Moreton, Christian, Schoneker, David, Putnam, Jennifer, Zeleznik, Joseph, Ulman, Katherine, Bremer, Stacey

“…Particle size is usually controlled as an average or distribution, and dilute solution viscosities are often used for routine analysis to monitor…”
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Comparison of Pharmaceutical Excipients and Food Ingredient Requirements by Grocholi, Luke, Zawislak, Priscilla, Moreton, R Christian, Ulman, Katherine L

“…[...]it is also incorrect to assume that product approved for use as a pharmaceutical excipient will automatically comply with food or dietary supplement…”
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Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements by Klug, David B, Lindblad, Ralph D, Muse, Douglas G, Ulman, Katherine L, Walsh, Phyllis, Zawislak, Priscilla S

“…[...]party audits offer a way to reduce the cost of audits, both for the pharmaceutical manufacturer and the excipient supplier. Followup communications…”
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Establishing limits for dermal absorption of elemental impurities by Teasdale, Andrew, Ulman, Katherine, Domoradzki, Jean, Walsh, Phyllis

“…The International Conference on Harmonization's (ICH's) Q3D Guideline For Elemental Impurities establishes acceptable exposure limits and defines these limits…”
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Mitigating the Risk from Excipient Variability: This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer by Carlin, Brian, Collins, George, Moreton, Christian, Schoneker, David, Putnam, Jennifer, Zeleznik, Joseph, Ulman, Katherine, Bremer, Stacey

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Elemental impurities: an industry perspective on harmonization and implementation of ICH and USP requirements by Ulman, Katherine, Schwarzwalder, Neil, Teasdale, Andrew, Schoneker, David, Zawislak, Priscilla

“…The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012, and are to be…”
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Additives and Processing Aids in Pharmaceutical Excipients: This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids by Collins, George, Ulman, Katherine, Muse, Douglas G, Tocce, Elizabeth, Zawislak, Priscilla, Zeleznik, Joseph

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Additives and Processing Aids in Pharmaceutical Excipients by Collins, George, Ulman, Katherine, Muse, Douglas G, Tocce, Elizabeth, Zawislak, Priscilla, Zeleznik, Joseph

“…[...]there are a large number of excipients in approved medicines that contain undeclared additives, processing aids, and/or concomitant components…”
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Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements: Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials by Klug, David B, Lindblad, Ralph D, Muse, Douglas G, Ulman, Katherine L, Walsh, Phyllis, Zawislak, Priscilla S

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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities by Teasdale, Andrew, Chéry, Cyrille C, Cook, Graham, Glennon, John, Harris, Laurence, Lee, Carlos W, Lewen, Nancy, Nethercote, Phil, Powell, Samuel, Rockstroh, Helmut, Rutter, Laura, Smallshaw, Lance, Thompson, Sarah, Woodward, Vicki, Ulman, Katherine

“…New guidelines relating to elemental impurities from the International Conference on Harmonization (ICH), Q3D Guideline for Elemental Impurities have presented…”
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Implementation of ICH Q3D elemental impurities guideline: challenges and opportunities: assessing risk factors is key to implementing the new ICH Q3D guidelines by Teasdale, Andrew, Chery, Cyrille C, Cook, Graham, Glennon, John, Harris, Laurence, Lee, Carlos W, Lewen, Nancy, Nethercote, Phil, Powell, Samuel, Rockstroh, Helmut, Rutter, Laura, Smallshaw, Lance, Thompson, Sarah, Woodward, Vicki, Ulman, Katherine

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