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Journal of Clinical Pharmacology|February 26, 2013
The combination of exposure-response and case-control analyses in regulatory decision makingJun Yang, Hong Zhao, Christine Garnett, et al.
The Oncologist|May 8, 2026
Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology productsYe Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.
The Oncologist|May 4, 2026
Shifting a Paradigm: Highlights of Model Informed Drug Development in Dosage Selection and Optimization for Oncology ProductsYe Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.
Bioanalysis|February 7, 2012
US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical ConsortiumFabio Garofolo, Josée Michon, Virginie Leclaire, et al.
Pharmaceutical Research|April 27, 2007
Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assaysC T Viswanathan, Surendra Bansal, Brian Booth, et al.
The AAPS Journal|April 30, 2015
Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated EnvironmentMarian Kelley, Lauren Stevenson, Michaela Golob, et al.
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|July 17, 2008
Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapiesRobert J Lechleider, Edvardas Kaminskas, Xiaoping Jiang, et al.
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|July 12, 2003
Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastasesAmna Ibrahim, Nancy Scher, Grant Williams, et al.
Oncology|June 10, 2010
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 transplantationMichael Brave, Ann Farrell, Sue Ching Lin, et al.
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|December 26, 2006
Sorafenib for the treatment of advanced renal cell carcinomaRobert C Kane, Ann T Farrell, Haleh Saber, et al.
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