Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs)
Tougas, Terrence P., Christopher, David, Mitchell, Jolyon P., Strickland, Helen, Wyka, Bruce, Van Oort, Mike, Lyapustina, Svetlana
Published in AAPS PharmSciTech (01.12.2009)
Published in AAPS PharmSciTech (01.12.2009)
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A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test
Novick, Steven, Christopher, David, Dey, Monisha, Lyapustina, Svetlana, Golden, Michael, Leiner, Stefan, Wyka, Bruce, Delzeit, Hans-Joachim, Novak, Chris, Larner, Gregory
Published in AAPS PharmSciTech (01.09.2009)
Published in AAPS PharmSciTech (01.09.2009)
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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence
Christopher, David, Adams, Wallace, Amann, Anthony, Bertha, Craig, Byron, Peter R, Doub, William, Dunbar, Craig, Hauck, Walter, Lyapustina, Svetlana, Mitchell, Jolyon, Morgan, Beth, Nichols, Steve, Pan, Ziqing, Singh, Gur Jai Pal, Tougas, Terrence, Tsong, Yi, Wolff, Ron, Wyka, Bruce
Published in AAPS PharmSciTech (01.10.2007)
Published in AAPS PharmSciTech (01.10.2007)
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A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 2—Effect of Changing Parameters
Novick, Steve, Christopher, David, Dey, Monisha, Lyapustina, Svetlana, Golden, Michael, Leiner, Stefan, Wyka, Bruce, Delzeit, Hans-Joachim, Novak, Chris, Larner, Gregory
Published in AAPS PharmSciTech (01.09.2009)
Published in AAPS PharmSciTech (01.09.2009)
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Journal Article
A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 3—Investigation of Robustness to Deviations from Normality
Novick, Steven, Christopher, David, Dey, Monisha, Lyapustina, Svetlana, Golden, Michael, Leiner, Stefan, Wyka, Bruce, Delzeit, Hans-Joachim, Novak, Chris, Larner, Gregory
Published in AAPS PharmSciTech (01.09.2009)
Published in AAPS PharmSciTech (01.09.2009)
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Journal Article
Minimizing Variability of Cascade Impaction Measurements in Inhalers and Nebulizers
Bonam, Matthew, Christopher, David, Cipolla, David, Donovan, Brent, Goodwin, David, Holmes, Susan, Lyapustina, Svetlana, Mitchell, Jolyon, Nichols, Steve, Pettersson, Gunilla, Quale, Chris, Rao, Nagaraja, Singh, Dilraj, Tougas, Terrence, Van Oort, Mike, Walther, Bernd, Wyka, Bruce
Published in AAPS PharmSciTech (01.06.2008)
Published in AAPS PharmSciTech (01.06.2008)
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Journal Article
Quality by Design for analytical methods for use with orally inhaled and nasal drug products
Rignall, Andy, Christopher, David, Crumpton, Andrew, Hawkins, Kevin, Lyapustina, Svetlana, Memmesheimer, Holger, Parkinson, Adrian, Smith, Mary Ann, Wyka, Bruce, Kaerger, Sebastian
Published in Pharmaceutical technology Europe (01.10.2008)
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Published in Pharmaceutical technology Europe (01.10.2008)
Journal Article
Quality by design for analytical methods for use with orally inhaled and nasal drug products; a discussion of what to consider when embarking on the development of analytical methods for use with orally inhaled and nasal drugs products, and where these points might fit in to a Quality by Design development programme
Rignall, Andy, Christopher, David, Crumpton, Andrew, Hawkins, Kevin, Lyapustina, Svetlana, Memmesheimer, Holger, Parkinson, Adrian, Smith, Mary Ann, Wyka, Bruce, Kaerger, Sebastian
Published in Pharmaceutical technology Europe (01.10.2008)
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Published in Pharmaceutical technology Europe (01.10.2008)
Journal Article
Considerations for the development and practice of cascade impaction testing, including a mass balance failure investigation tree
Christopher, Dave, Curry, Paul, Doub, Bill, Furnkranz, Kenneth, Lavery, Martin, Lin, Karl, Lyapustina, Svetlana, Mitchell, Jolyon, Rogers, Brian, Strickland, Helen, Tougas, Terrence, Tsong, Yi, Wyka, Bruce
Published in Journal of aerosol medicine (01.09.2003)
Published in Journal of aerosol medicine (01.09.2003)
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Journal Article
Compatibility and stability of labetalol hydrochloride in commonly used intravenous solutions
Yuen, P H, Taddei, C R, Wyka, B E, Chaudry, I A
Published in American journal of hospital pharmacy (01.06.1983)
Published in American journal of hospital pharmacy (01.06.1983)
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