Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary
THORNTON, Katherine, KIM, Geoffrey, GARNETT, Christine, QI LIU, BOOTH, Brian, GEHRKE, Brenda, DORSAM, Robert, VERBOIS, Leigh, GHOSH, Debasis, WILSON, Wendy, DUAN, John, SARKER, Haripada, MAHER, V. Ellen, POPE MIKSINSKI, Sarah, SKARUPA, Lisa, IBRAHIM, Amna, JUSTICE, Robert, MURGO, Anthony, PAZDUR, Richard, CHATTOPADHYAY, Somesh, SHENGHUI TANG, YOUNG JIN MOON, PENGFEI SONG, MARATHE, Anshu, BALAKRISHNAN, Suchitra, HAO ZHU
Published in Clinical cancer research (15.07.2012)
Published in Clinical cancer research (15.07.2012)
Get full text
Journal Article
FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation
Brave, Michael, Farrell, Ann, Ching Lin, Sue, Ocheltree, Terrance, Pope Miksinski, Sarah, Lee, Shwu-Luan, Saber, Haleh, Fourie, Jeanne, Tornoe, Christoffer, Booth, Brian, Yuan, Weishi, He, Kun, Justice, Robert, Pazdur, Richard
Published in Oncology (01.01.2010)
Published in Oncology (01.01.2010)
Get full text
Journal Article
FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer
AMIRI-KORDESTANI, Laleh, BLUMENTHAL, Gideon M, RUSSELL, Anne M, MIKSINSKI, Sarah Pope, XIAO HONG CHEN, McGUINN, W. David, PALMBY, Todd, SCHRIEBER, Sarah J, QI LIU, JIAN WANG, PENGFEI SONG, MEHROTRA, Nitin, QIANG CASEY XU, SKARUPA, Lisa, CLOUSE, Kathleen, AL-HAKIM, Ali, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, CORTAZAR, Patricia, LIJUN ZHANG, TANG, Shenghui W, LINAN HA, WEINBERG, Wendy C, BO CHI, CANDAU-CHACON, Reyes, HUGHES, Patricia
Published in Clinical cancer research (01.09.2014)
Published in Clinical cancer research (01.09.2014)
Get full text
Journal Article
Dissolution Testing in Drug Product Development: Workshop Summary Report
Abend, Andreas, Curran, David, Kuiper, Jesse, Lu, Xujin, Li, Hanlin, Hermans, Andre, Kotwal, Pramod, Diaz, Dorys A., Cohen, Michael J., Zhang, Limin, Stippler, Erika, Drazer, German, Lin, Yiqing, Raines, Kimberly, Yu, Lawrence, Coutant, Carrie A., Grady, Haiyan, Krämer, Johannes, Pope-Miksinski, Sarah, Suarez-Sharp, Sandra
Published in The AAPS journal (01.03.2019)
Published in The AAPS journal (01.03.2019)
Get full text
Journal Article
Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development
Li, Min, Sander, Sanna, Duan, John, Rosencrance, Susan, Miksinski, Sarah Pope, Yu, Lawrence, Seo, Paul, Rege, Bhagwant
Published in The AAPS journal (01.11.2016)
Published in The AAPS journal (01.11.2016)
Get full text
Journal Article
Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications
Suarez-Sharp, Sandra, Delvadia, Poonam R., Dorantes, Angelica, Duan, John, Externbrink, Anna, Gao, Zongming, Ghosh, Tapash, Miksinski, Sarah Pope, Seo, Paul
Published in The AAPS journal (01.05.2016)
Published in The AAPS journal (01.05.2016)
Get full text
Journal Article
Examining Manufacturing Readiness for Breakthrough Drug Development
Dye, Earl, Sturgess, Annie, Maheshwari, Gargi, May, Kimberly, Ruegger, Colleen, Ramesh, Usha, Tan, Heow, Cockerill, Keith, Groskoph, John, Lacana, Emanuela, Lee, Sau, Miksinski, Sarah Pope
Published in AAPS PharmSciTech (01.06.2016)
Published in AAPS PharmSciTech (01.06.2016)
Get full text
Journal Article
FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation
Kim, Geoffrey, McKee, Amy E, Ning, Yang-Min, Hazarika, Maitreyee, Theoret, Marc, Johnson, John R, Xu, Qiang Casey, Tang, Shenghui, Sridhara, Rajeshwari, Jiang, Xiaoping, He, Kun, Roscoe, Donna, McGuinn, W David, Helms, Whitney S, Russell, Anne Marie, Miksinski, Sarah Pope, Zirkelbach, Jeanne Fourie, Earp, Justin, Liu, Qi, Ibrahim, Amna, Justice, Robert, Pazdur, Richard
Published in Clinical cancer research (01.10.2014)
Published in Clinical cancer research (01.10.2014)
Get full text
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)
Get full text
Journal Article
Conference Proceeding