Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations
Norwood, Daniel L., Paskiet, Diane, Ruberto, Michael, Feinberg, Thomas, Schroeder, Alan, Poochikian, Guirag, Wang, Qingxi, Deng, Tian Jing, DeGrazio, Fran, Munos, Melinda K., Nagao, Lee M.
Published in Pharmaceutical research (01.04.2008)
Published in Pharmaceutical research (01.04.2008)
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Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products
Jenke, Dennis, Egert, Thomas, Hendricker, Alan, Castner, James, Feinberg, Tom, Houston, Christopher, Hunt, Desmond G, Lynch, Michael, Nicholas, Kumudini, Norwood, Daniel L, Paskiet, Diane, Ruberto, Michael, Smith, Edward J, Holcomb, Frank, Markovic, Ingrid
Published in PDA journal of pharmaceutical science and technology (01.03.2017)
Published in PDA journal of pharmaceutical science and technology (01.03.2017)
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Journal Article
The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
Paskiet, Diane, Jenke, Dennis, Ball, Douglas, Houston, Christopher, Norwood, Daniel L, Markovic, Ingrid
Published in PDA journal of pharmaceutical science and technology (01.09.2013)
Published in PDA journal of pharmaceutical science and technology (01.09.2013)
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Journal Article
Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation
Ball, Douglas, Blanchard, James, Jacobson-Kram, David, McClellan, Roger O, McGovern, Timothy, Norwood, Daniel L, Vogel, WMark, Wolff, Ron, Nagao, Lee
Published in Toxicological sciences (01.06.2007)
Published in Toxicological sciences (01.06.2007)
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Journal Article
Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products
Jenke, Dennis, Castner, James, Egert, Thomas, Feinberg, Tom, Hendricker, Alan, Houston, Christopher, Hunt, Desmond G, Lynch, Michael, Shaw, Arthur, Nicholas, Kumudini, Norwood, Daniel L, Paskiet, Diane, Ruberto, Michael, Smith, Edward J, Holcomb, Frank
Published in PDA journal of pharmaceutical science and technology (01.09.2013)
Published in PDA journal of pharmaceutical science and technology (01.09.2013)
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Journal Article
Recent Advances in Headspace Gas Chromatography
Wang, Yuwen, McCaffrey, John, Norwood, Daniel L.
Published in Journal of liquid chromatography & related technologies (18.06.2008)
Published in Journal of liquid chromatography & related technologies (18.06.2008)
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Journal Article
Identification of a process impurity formed during synthesis of a nevirapine analogue HIV NNRT inhibitor using LC/MS and forced degradation studies
Qiu, Fenghe, Pennino, Scott, Busacca, Carl A., Norwood, Daniel L.
Published in Journal of pharmaceutical and biomedical analysis (05.04.2009)
Published in Journal of pharmaceutical and biomedical analysis (05.04.2009)
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Journal Article
(31)P solid state NMR study of structure and chemical stability of dichlorotriphenylphosphorane
Gonnella, Nina C, Busacca, Carl, Campbell, Scot, Eriksson, Magnus, Grinberg, Nelu, Bartholomeyzik, Teresa, Ma, Shengli, Norwood, Daniel L
Published in Magnetic resonance in chemistry (01.06.2009)
Published in Magnetic resonance in chemistry (01.06.2009)
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Journal Article
Perspectives on the PQRI Extractables and Leachables "Safety Thresholds and Best Practices" Recommendations for Inhalation Drug Products
Norwood, Daniel L, Nagao, Lee M, Stults, Cheryl L M
Published in PDA journal of pharmaceutical science and technology (01.09.2013)
Published in PDA journal of pharmaceutical science and technology (01.09.2013)
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Journal Article
Study and characterization of crystalline hydrate/polymorph forms of 5,11-dihydro-11-ethyl-5-methyl-8-(2-(1-oxido-4-quinolinyl)ethyl-6H-dipyrido(3,2-B:2′,3′-E)(1,4)diazepin-6-one by solid-state NMR and solution NMR
Gonnella, N.C., Smoliga, John A., Campbell, Scot, Busacca, Carl A., Cerreta, Michael, Varsolona, Richard, Norwood, Daniel L.
Published in Journal of pharmaceutical and biomedical analysis (06.04.2010)
Published in Journal of pharmaceutical and biomedical analysis (06.04.2010)
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Journal Article
Automated Solid Phase Extraction (SPE) LC/NMR Applied to the Structural Analysis of Extractable Compounds from a Pharmaceutical Packaging Material of Construction
Norwood, Daniel L, Mullis, James O, Davis, Mark, Pennino, Scott, Egert, Thomas, Gonnella, Nina C
Published in PDA journal of pharmaceutical science and technology (01.05.2013)
Published in PDA journal of pharmaceutical science and technology (01.05.2013)
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Journal Article
Genotoxic Impurities: A Quantitative Approach
Yuabova, Zhanna Y., Holschlag, David R., Rodriguez, Shirley A., Qin, Cindy, Papov, Vladimir V., Qiu, Fenghe, McCaffrey, John F., Norwood, Daniel L.
Published in Journal of liquid chromatography & related technologies (08.08.2008)
Published in Journal of liquid chromatography & related technologies (08.08.2008)
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Journal Article
Conference Proceeding
Effects of Perchloric Acid on High Temperature Liquid Chromatography
Wang, Yuwen, Grinberg, Nelu, McCaffrey, John, Norwood, Daniel L.
Published in Journal of liquid chromatography & related technologies (08.08.2008)
Published in Journal of liquid chromatography & related technologies (08.08.2008)
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Journal Article
Conference Proceeding
Structural characterization of aquatic humic material. 2. Phenolic content and its relationship to chlorination mechanism in an isolated aquatic fulvic acid
Norwood, Daniel L, Christman, Russell F, Hatcher, Patrick G
Published in Environmental science & technology (01.08.1987)
Published in Environmental science & technology (01.08.1987)
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Journal Article
Identification of Drug Meglumine Interaction Products Using LC/MS and Forced Degradation Studies
Qiu, Fenghe, Cobice, Diego, Pennino, Scott, Becher, Mariela, Norwood, Daniel L.
Published in Journal of liquid chromatography & related technologies (08.08.2008)
Published in Journal of liquid chromatography & related technologies (08.08.2008)
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Journal Article
Conference Proceeding
Identification of Pharmaceutical Impurities
Qiu, Fenghe, Norwood, Daniel L.
Published in Journal of liquid chromatography & related technologies (01.02.2007)
Published in Journal of liquid chromatography & related technologies (01.02.2007)
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Journal Article