Equivalence of complex drug products: advances in and challenges for current regulatory frameworks von Hussaarts, Leonie, Mühlebach, Stefan, Shah, Vinod P., McNeil, Scott, Borchard, Gerrit, Flühmann, Beat, Weinstein, Vera, Neervannan, Sesha, Griffiths, Elwyn, Jiang, Wenlei, Wolff‐Holz, Elena, Crommelin, Daan J.A., Vlieger, Jon S.B.

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The Co‐Crystal Approach to Improve the Exposure of a Water‐Insoluble Compound: AMG 517 Sorbic Acid Co‐Crystal Characterization and Pharmacokinetics von Bak, Annette, Gore, Anu, Yanez, Evelyn, Stanton, Mary, Tufekcic, Sunita, Syed, Rashid, Akrami, Anna, Rose, Mark, Surapaneni, Sekhar, Bostick, Tracy, King, Anthony, Neervannan, Sesha, Ostovic, Drazen, Koparkar, Arun

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Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis von Davey, Pinakin Gunvant, Farid, Marjan, Karpecki, Paul, Gaddie, Ian Benjamin, Chan, Arthur, Mun, James, Neervannan, Sesha, Yeu, Elizabeth

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Characterization of thermal behavior of deep eutectic solvents and their potential as drug solubilization vehicles von Morrison, Henry G., Sun, Changquan C., Neervannan, Sesha

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Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials” von de Vlieger, Jon S. B., Crommelin, Daan J. A., Tyner, Katherine, Drummond, Daryl C., Jiang, Wenlei, McNeil, Scott E., Neervannan, Sesha, Crist, Rachael M., Shah, Vinod P.

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AMG 706, an oral, multikinase inhibitor that selectively targets vascular endothelial growth factor, platelet-derived growth factor, and kit receptors, potently inhibits angiogenes... von POLVERINO, Anthony, COXON, Angela, DANLIN CHEN, YONGMEI GAN, KUMAR, Gondi, MEYER, James, NEERVANNAN, Sesha, ALVA, Gonzalo, TALVENHEIMO, Jane, MONTESTRUQUE, Silvia, TASKER, Andrew, PATEL, Vinod, STARNES, Charlie, RADINSKY, Robert, KENDALL, Richard, DIAZ, Zobedia, DEMELFI, Thomas, LING WANG, BREADY, James, ESTRADA, Juan, CATTLEY, Russell, KAUFMAN, Stephen

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Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease von Gore, Anu, Attar, Mayssa, Pujara, Chetan, Neervannan, Sesha

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Comment on “Quality by Design Approach for Understanding the Critical Quality Attributes of Cyclosporine Ophthalmic Emulsion” von Gore, Anuradha, Attar, Mayssa, Pujara, Chetan, Neervannan, Sesha

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Naphthamides as Novel and Potent Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors: Design, Synthesis, and Evaluation von Harmange, Jean-Christophe, Weiss, Matthew M, Germain, Julie, Polverino, Anthony J, Borg, George, Bready, James, Chen, Danlin, Choquette, Deborah, Coxon, Angela, DeMelfi, Tom, DiPietro, Lucian, Doerr, Nicholas, Estrada, Juan, Flynn, Julie, Graceffa, Russell F, Harriman, Shawn P, Kaufman, Stephen, La, Daniel S, Long, Alexander, Martin, Matthew W, Neervannan, Sesha, Patel, Vinod F, Potashman, Michele, Regal, Kelly, Roveto, Phillip M, Schrag, Michael L, Starnes, Charlie, Tasker, Andrew, Teffera, Yohannes, Wang, Ling, White, Ryan D, Whittington, Douglas A, Zanon, Roger

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Is the EU ready for non-biological complex drug products? von de Vlieger, Jon S.B, Borchard, Gerrit, Shah, Vinod P, Fluhmann, Beat, Neervannan, Sesha, Muhlebach, Stefan

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Evaluation of a Series of Naphthamides as Potent, Orally Active Vascular Endothelial Growth Factor Receptor-2 Tyrosine Kinase Inhibitors von Weiss, Matthew M, Harmange, Jean-Christophe, Polverino, Anthony J, Bauer, David, Berry, Loren, Berry, Virginia, Borg, George, Bready, James, Chen, Danlin, Choquette, Deborah, Coxon, Angela, DeMelfi, Tom, Doerr, Nicholas, Estrada, Juan, Flynn, Julie, Graceffa, Russell F, Harriman, Shawn P, Kaufman, Stephen, La, Daniel S, Long, Alexander, Neervannan, Sesha, Patel, Vinod F, Potashman, Michele, Regal, Kelly, Roveto, Phillip M, Schrag, Michael L, Starnes, Charlie, Tasker, Andrew, Teffera, Yohannes, Whittington, Douglas A, Zanon, Roger

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Non-biological complex drugs (NBCDs) and their follow-on versions: time for an editorial section von de Vlieger, Jon S.B, Muhlebach, Stefan, Shah, Vinod P, McNeil, Scott E, Borchard, Gerrit, Weinstein, Vera, Fluhmann, Beat, Neervannan, Sesha, Crommelin, Daan J.A

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Discovery of N-phenyl nicotinamides as potent inhibitors of Kdr von Dominguez, Celia, Smith, Leon, Huang, Qi, Yuan, Chester, Ouyang, Xiaohu, Cai, Lynn, Chen, Paul, Kim, Joseph, Harvey, Timothy, Syed, Rashid, Kim, Tae-Seong, Tasker, Andrew, Wang, Ling, Zhang, Michael, Coxon, Angela, Bready, James, Starnes, Charles, Chen, Danlin, Gan, Yongmei, Neervannan, Sesha, Kumar, Gondi, Polverino, Anthony, Kendall, Richard

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SUSPENSION COMPOSITIONS OF CYCLOSPORIN A FOR SUBCONJUNCTIVAL AND PERIOCULAR INJECTION von NEERVANNAN, SESHA, WU, KE, PUJARA, CHETAN P, GORE, ANURADHA V, HOU, HAO

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FIXED DOSE COMBINATION OF BROMONIDINE AND TIMOLOL von PUJARA, Chetan P, GRAHAM, Richard S, SHEN, Jie, JIAO, Jim, CHANG, Chin-Ming, JORDAN, R. Scott, GORE, Anuradha V, WARNER, Kevin S, NEERVANNAN, Sesha

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FIXED DOSE COMBINATION OF BROMONIDINE AND TIMOLOL von PUJARA, Chetan P, GRAHAM, Richard S, SHEN, Jie, JIAO, Jim, CHANG, Chin-Ming, JORDAN, R. Scott, GORE, Anuradha V, WARNER, Kevin S, NEERVANNAN, Sesha

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FIXED DOSE COMBINATION OF BRIMONIDINE AND TIMOLOL von PUJARA, Chetan P, GRAHAM, Richard S, SHEN, Jie, JIAO, Jim, CHANG, Chin-Ming, JORDAN, R. Scott, GORE, Anuradha V, WARNER, Kevin S, NEERVANNAN, Sesha

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Fixed dose combination of brimonidine and timolo von Jiao, Jim, Shen, Jie, Warner, Kevin S, Chang, Chin-Ming, Gore, Anuradha V, Pujara, Chetan P, Graham, Richard S, Neervannan, Sesha, Jordan, R. Scott

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Microneedle array with active ingredient von Lu, Guang Wei, Liu, Futian, Yu, Xiaojie, Steward, Lance E, Neervannan, Sesha, Hughes, Patrick M

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FIXED DOSE COMBINATION OF BRIMONIDINE AND TIMOLOL von Jiao, Jim, Shen, Jie, Warner, Kevin S, Chang, Chin-Ming, Gore, Anuradha V, Pujara, Chetan P, Graham, Richard S, Neervannan, Sesha, Jordan, R. Scott

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