Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape
Alsante, Karen M., Huynh-Ba, Kim C., Baertschi, Steven W., Reed, Robert A., Landis, Margaret S., Furness, Scott, Olsen, Bernard, Mowery, Mark, Russo, Karen, Iser, Robert, Stephenson, Gregory A., Jansen, Patrick
Published in AAPS PharmSciTech (01.02.2014)
Published in AAPS PharmSciTech (01.02.2014)
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Journal Article
Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
Yu, Lawrence X., Akseli, Ilgaz, Allen, Barbara, Amidon, Gregory, Bizjak, Tara Gooen, Boam, Ashley, Caulk, Margaret, Doleski, David, Famulare, Joseph, Fisher, Adam C., Furness, Scott, Hasselbalch, Brian, Havel, Henry, Hoag, Stephen W., Iser, Robert, Johnson, Bruce D., Ju, Robert, Katz, Paula, Lacana, Emanuela, Lee, Sau L., Lostritto, Richard, McNally, Grace, Mehta, Mehul, Mohan, Ganapathy, Nasr, Moheb, Nosal, Roger, Oates, Mary, O’Connor, Thomas, Polli, Jim, Raju, G. K., Ramanadham, Mahesh, Randazzo, Giuseppe, Rosencrance, Susan, Schwendeman, Anna, Selen, Arzu, Seo, Paul, Shah, Vinod, Sood, Ramesh, Thien, Michael P., Tong, Tony, Trout, Bernhardt L., Tyner, Katherine, Vaithiyalingam, Siva, VanTrieste, Martin, Walsh, Fionnuala, Wesdyk, Russell, Woodcock, Janet, Wu, Geoffrey, Wu, Larisa, Yu, Louis, Zezza, Diane
Published in The AAPS journal (01.03.2016)
Published in The AAPS journal (01.03.2016)
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Journal Article
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
Yu, Lawrence X., Baker, Jeffrey, Berlam, Susan C., Boam, Ashley, Brandreth, E. J., Buhse, Lucinda, Cosgrove, Thomas, Doleski, David, Ensor, Lynne, Famulare, Joseph, Ganapathy, Mohan, Grampp, Gustavo, Hussong, David, Iser, Robert, Johnston, Gordon, Kesisoglou, Filippos, Khan, Mansoor, Kozlowski, Steven, Lacana, Emanuela, Lee, Sau L., Miller, Stephen, Miksinski, Sarah Pope, Moore, Christine M. V., Mullin, Theresa, Raju, G. K., Raw, Andre, Rosencrance, Susan, Rosolowsky, Mark, Stinavage, Paul, Thomas, Hayden, Wesdyk, Russell, Windisch, Joerg, Vaithiyalingam, Sivakumar
Published in The AAPS journal (01.07.2015)
Published in The AAPS journal (01.07.2015)
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Journal Article
Conference Proceeding
Common Deficiencies in Abbreviated New Drug Applications
Srinivasan, Aloka, Iser, Robert, Gill, Devinder S
Published in Pharmaceutical Technology (01.02.2011)
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Published in Pharmaceutical Technology (01.02.2011)
Trade Publication Article
Common Deficiencies in Abbreviated New Drug Applications Part 1: Drug Substance
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Trade Publication Article
Common deficiencies in abbreviated new drug applications: Part I: drug substance
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Magazine Article
Trade Publication Article
Common deficiencies in abbreviated new drug applications: Part IV: manufacture (2.3.P3) and container closure system (2.3.P.7)
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Magazine Article
Trade Publication Article
Common deficiencies in abbreviated new drug applications: part 1: drug substance: team leaders in the US Food and Drug Administration's Office of Generic Drugs provide an overview of common deficiencies cited throughout the Chemistry, Manufacturing, and Controls section of abbreviated new drug applications (ANDAs)
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Magazine Article
Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience
Lovett, Grace C, Nguyen, Tin, Iser, David M, Holmes, Jacinta A, Chen, Robert, Demediuk, Barbara, Shaw, Gideon, Bell, Sally J, Desmond, Paul V, Thompson, Alexander J
Published in World journal of hepatology (08.01.2017)
Published in World journal of hepatology (08.01.2017)
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Journal Article
Common deficiencies in abbreviated new drug applications: Part III: control of the drug product and stability
Srinivasan, Aloka, Iser, Robert, Gill, Devinder S
Published in Pharmaceutical Technology (01.07.2011)
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Published in Pharmaceutical Technology (01.07.2011)
Magazine Article
Trade Publication Article
Common Deficiences in Abbreviated New Drug Applications: Part II: Description, Composition, and Excipients
Srinivasan, Aloka, Iser, Robert, Gill, Devinder S
Published in Pharmaceutical Technology (01.07.2011)
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Published in Pharmaceutical Technology (01.07.2011)
Magazine Article
Trade Publication Article
Common deficiences in abbreviated new drug applications: part 2: description, composition, and excipients
Srinivasan, Aloka, Iser, Robert, Gill, Devinder S
Published in Pharmaceutical Technology (01.08.2010)
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Published in Pharmaceutical Technology (01.08.2010)
Magazine Article
Trade Publication Article