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	1.	Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development. [electronic resource] by Li, Min Sander, Sanna Duan, John Rosencrance, Susan Miksinski, Sarah Pope Yu, Lawrence Seo, Paul Rege, Bhagwant Producer: 20170120 In: The AAPS journal vol. 18 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	2.	Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications. [electronic resource] by Suarez-Sharp, Sandra Delvadia, Poonam R Dorantes, Angelica Duan, John Externbrink, Anna Gao, Zongming Ghosh, Tapash Miksinski, Sarah Pope Seo, Paul Producer: 20170201 In: The AAPS journal vol. 18 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	3.	Examining Manufacturing Readiness for Breakthrough Drug Development. [electronic resource] by 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 Producer: 20170120 In: AAPS PharmSciTech vol. 17 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	4.	U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma. [electronic resource] by Axelson, Michael Liu, Ke Jiang, Xiaoping He, Kun Wang, Jian Zhao, Hong Kufrin, Dubravka Palmby, Todd Dong, Zedong Russell, Anne Marie Miksinski, Sarah Keegan, Patricia Pazdur, Richard Producer: 20131112 In: Clinical cancer research : an official journal of the American Association for Cancer Research vol. 19 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	5.	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. [electronic resource] by 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 Producer: 20100721 In: Oncology vol. 78 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	6.	Dissolution Testing in Drug Product Development: Workshop Summary Report. [electronic resource] by 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 Producer: 20200214 In: The AAPS journal vol. 21 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	7.	FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation. [electronic resource] by 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 Producer: 20150625 In: Clinical cancer research : an official journal of the American Association for Cancer Research vol. 20 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	8.	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. [electronic resource] by Thornton, Katherine Kim, Geoffrey Maher, V Ellen Chattopadhyay, Somesh Tang, Shenghui Moon, Young Jin Song, Pengfei Marathe, Anshu Balakrishnan, Suchitra Zhu, Hao Garnett, Christine Liu, Qi Booth, Brian Gehrke, Brenda Dorsam, Robert Verbois, Leigh Ghosh, Debasis Wilson, Wendy Duan, John Sarker, Haripada Miksinski, Sarah Pope Skarupa, Lisa Ibrahim, Amna Justice, Robert Murgo, Anthony Pazdur, Richard Producer: 20130403 In: Clinical cancer research : an official journal of the American Association for Cancer Research vol. 18 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	9.	Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference. [electronic resource] by 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 Producer: 20160325 In: The AAPS journal vol. 17 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)
	10.	FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer. [electronic resource] by Amiri-Kordestani, Laleh Blumenthal, Gideon M Xu, Qiang Casey Zhang, Lijun Tang, Shenghui W Ha, Linan Weinberg, Wendy C Chi, Bo Candau-Chacon, Reyes Hughes, Patricia Russell, Anne M Miksinski, Sarah Pope Chen, Xiao Hong McGuinn, W David Palmby, Todd Schrieber, Sarah J Liu, Qi Wang, Jian Song, Pengfei Mehrotra, Nitin Skarupa, Lisa Clouse, Kathleen Al-Hakim, Ali Sridhara, Rajeshwari Ibrahim, Amna Justice, Robert Pazdur, Richard Cortazar, Patricia Producer: 20150707 In: Clinical cancer research : an official journal of the American Association for Cancer Research vol. 20 Online resources: Available from publisher's website Availability: No items available. Save to lists Add to cart (remove)