Relevance of distinctions and parallels between the US and EU guidelines for determination of comparative effectiveness and safety of the orally inhaled drug products von Singh, Gur Jai Pal

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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 von 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

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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: part 2--evaluation of a method for determining equivalence von Christopher, David, Adams, Wallace P, Lee, Douglas S, Morgan, Beth, Pan, Ziqing, Singh, Gur Jai Pal, Tsong, Yi, Lyapustina, Svetlana

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Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report von Evans, Carole, Cipolla, David, Chesworth, Tim, Agurell, Eva, Ahrens, Richard, Conner, Dale, Dissanayake, Sanjeeva, Dolovich, Myrna, Doub, William, Fuglsang, Anders, García Arieta, Afredo, Golden, Michael, Hermann, Robert, Hochhaus, Günther, Holmes, Susan, Lafferty, Paul, Lyapustina, Svetlana, Nair, Parameswaran, O'Connor, Dennis, Parkins, David, Peterson, Ilse, Reisner, Colin, Sandell, Dennis, Singh, Gur Jai Pal, Weda, Marjolein, Watson, Patricia

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Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose von Singh, Gur Jai Pal, Hickey, Anthony J

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Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report von Adams, Wallace P, Ahrens, Richard C, Chen, Mei-Ling, Christopher, David, Chowdhury, Badrul A, Conner, Dale P, Dalby, Richard, Fitzgerald, Kevin, Hendeles, Leslie, Hickey, Anthony J, Hochhaus, Günther, Laube, Beth L, Lucas, Paul, Lee, Sau L, Lyapustina, Svetlana, Li, Bing, O'Connor, Dennis, Parikh, Neil, Parkins, David A, Peri, Prasad, Pitcairn, Gary R, Riebe, Michael, Roy, Partha, Shah, Tushar, Singh, Gur Jai Pal, Sharp, Sandra Suarez, Suman, Julie D, Weda, Marjolein, Woodcock, Janet, Yu, Lawrence

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Prediction of the carrier shape effect on particle transport, interaction and deposition in two dry powder inhalers and a mouth-to-G13 human respiratory system: A CFD-DEM study von Zhao, Jianan, Haghnegahdar, Ahmadreza, Feng, Yu, Patil, Abhijeet, Kulkarni, Nandan, Singh, Gur Jai Pal, Malhotra, Geena, Bharadwaj, Rahul

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Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: background for a statistical method von Adams, Wallace P, Christopher, David, Lee, Douglas S, Morgan, Beth, Pan, Ziqing, Singh, Gur Jai Pal, Tsong, Yi, Lyapustina, Svetlana

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Scientific Rationale for Determining the Bioequivalence of Inhaled Drugs von Usmani, Omar S., Molimard, Mathieu, Gaur, Vaibhav, Gogtay, Jaideep, Singh, Gur Jai Pal, Malhotra, Geena, Derom, Eric

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A methacholine challenge dose-response study for development of a pharmacodynamic bioequivalence methodology for albuterol metered-dose inhalers von Creticos, Peter S., Adams, Wallace P., Petty, Brent G., Lewis, Lionel D., Singh, Gur Jai Pal, Khattignavong, Arouna P., Molzon, Justina A., Martinez, Marilyn N., Lietman, Paul S., Williams, Roger L.

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Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling von Singh, Gur Jai Pal, Adams, Wallace P., Lesko, Lawrence J., Shah, Vinod P., Molzon, Justina A., Williams, Roger L., Pershing, Lynn K.

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Conference Report: Bio-International 2005 von Midha, Kamal K., Shah, Vinod P., Singh, Gur Jai Pal, Patnaik, Rabi

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Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report von O'Connor, Dennis, Adams, Wallace P, Chen, Mei-Ling, Daley-Yates, Peter, Davis, John, Derendorf, Hartmut, Ducharme, Murray P, Fuglsang, Anders, Herrle, Myra, Hochhaus, Günther, Holmes, Susan M, Lee, Sau L, Li, Bing V, Lyapustina, Svetlana, Newman, Stephen, Oliver, Martin, Patterson, Beverley, Peart, Joanne, Poochikian, Guirag, Roy, Partha, Shah, Tushar, Singh, Gur Jai Pal, Sharp, Sandra Suarez

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Hemolymph carbohydrate and lipid mobilization in Locusta migratoria in relation to the progress of poisoning following bioresmethrin treatment von Singh, Gur Jai Pal

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An electron microscope study of the toxic action of Bacillus sphaericus in Culex quinquefasciatus larvae von Singh, Gur Jai Pal, Gill, Sarjeet S.

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Preliminary X-ray diffraction analysis of crystals of Bacillus thuringiensis toxin, a cell membrane disrupting protein von McPherson, Alexander, Jurnak, Frances, Singh, Gur Jai Pal, Gill, Sarjeet S.

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Effect of food on absorption of Dilantin Kapseals and Mylan extended phenytoin sodium capsules von Davit, Barbara M, Singh, Gur Jai Pal, Conner, Dale P

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Action of bioresmethrin on the corpus cardiacum of Locusta migratoria von Singh, Gur Jai Pal, Orchard, Ian

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Action of Bacillus thuringiensis subsp. israelensis δ-endotoxin on the ultrastructure of the house fly larva neuromuscular system in vitro von Singh, Gur Jai Pal, Schouest, Leo P., Gill, Sarjeet S.

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Chitinases in the house fly, Musca domestica: Pattern of activity in the life cycle and preliminary characterization von Singh, Gur Jai Pal, Vardanis, A.

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