Search Results - "SHORD, Stacy S"

Epigenetics and Oncology by Mummaneni, Padmaja, Shord, Stacy S.

“…Epigenetic modifications play a critical role in the development of pediatric and adult cancers, contributing to the cumulative changes observed as normal…”
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US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer by Shord, Stacy S., Zhu, Hao, Liu, Jiang, Rahman, Atiqur, Booth, Brian, Zineh, Issam

“…Translational strategies that iteratively evaluate emerging data should be considered to increase the likelihood of identifying dosages that optimize the…”
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Study design considerations to assess the impact of potential drug–drug interactions in first‐in‐human studies in oncology drug development by Subramaniam, Sriram, Shord, Stacy S., Leong, Ruby, Norsworthy, Kelly, Rahman, Atiqur, Booth, Brian, Okusanya, Olanrewaju

“…First-in-human studies are limited to patients with serious diseases for which no curative therapies are available to ensure that the benefits outweigh the…”
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Understanding and managing the possible adverse effects associated with bevacizumab by Shord, Stacy S, Bressler, Linda R, Tierney, Lauryn A, Cuellar, Sandra, George, Amina

“…The adverse events associated with bevacizumab therapy are characterized, and the underlying pathophysiology, risk factors, frequency, and management of these…”
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Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs by Rahman, Atiqur, Shah, Mirat, Shord, Stacy S.

“…Optimized dosages provide a secure foundation for the development of well‐tolerated and effective oncology drugs. Project Optimus, an initiative within the…”
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FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome by Le, Robert Q., Li, Liang, Yuan, Weishi, Shord, Stacy S., Nie, Lei, Habtemariam, Bahru A., Przepiorka, Donna, Farrell, Ann T., Pazdur, Richard

“…On August 30, 2017, the U.S. Food and Drug Administration approved Actemra (tocilizumab, Genentech, Inc., South San Francisco, CA) for the treatment of severe…”
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Drug—Botanical Interactions: A Review of the Laboratory, Animal, and Human Data for 8 Common Botanicals by Shord, Stacy S., Shah, Kanan, Lukose, Alvina

“…Many Americans use complementary and alternative medicine (CAM) to prevent or alleviate common illnesses, and these medicines are commonly used by individuals…”
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Validation of Bupropion Hydroxylation as a Selective Marker of Human Cytochrome P450 2B6 Catalytic Activity by FAUCETTE, Stephanie R, HAWKE, Roy L, LECLUYSE, Edward L, SHORD, Stacy S, BINGFANG YAN, LAETHEM, Ronald M, LINDLEY, Celeste M

“…The purpose of this study was to establish bupropion (BUP) hydroxylation as a selective in vitro marker of cytochrome P450 (CYP) 2B6 catalytic activity. Among…”
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FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia by Krauss, Aviva C, Gao, Xin, Li, Liang, Manning, Michael L, Patel, Paresma, Fu, Wentao, Janoria, Kumar G, Gieser, Gerlie, Bateman, David A, Przepiorka, Donna, Shen, Yuan Li, Shord, Stacy S, Sheth, Christopher M, Banerjee, Anamitro, Liu, Jiang, Goldberg, Kirsten B, Farrell, Ann T, Blumenthal, Gideon M, Pazdur, Richard

“…On August 3, 2017, the FDA granted regular approval to Vyxeos (also known as CPX-351; Jazz Pharmaceuticals), a liposomal formulation of daunorubicin and…”
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The interactions of anti-cancer drugs approved in the last decade in the United States with membrane transporters by Jain, Lokesh, Abraham, Sophia, Shord, Stacy S

“…Membrane transporters play a role in determining the absorption, distribution, metabolism and excretion of small molecule anticancer drugs and mediating…”
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The Role of Clinical Pharmacology in Oncology Dose Selection: Advances and Opportunities in Personalized Medicine by Shord, Stacy S.

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Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress by Charlab, Rosane, Leong, Ruby, Shord, Stacy S, Reaman, Gregory H

“…The discovery and development of anticancer drugs for pediatric patients have historically languished when compared to both past and recent activity in drug…”
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Effects of oral clotrimazole troches on the pharmacokinetics of oral and intravenous midazolam by Shord, Stacy S., Chan, Lingtak‐Neander, Camp, Joseph R., Vasquez, Eva M., Jeong, Hyun‐Young, Molokie, Robert E., Baum, Charles L., Xie, Hui

“…WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Clotrimazole troches are commonly used as prophylaxis for thrush that may develop in immunocompromised patients. •…”
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FDA Approval Summary: Selumetinib for Plexiform Neurofibroma by Casey, Denise, Demko, Suzanne, Sinha, Arup, Mishra-Kalyani, Pallavi S, Shen, Yuan-Li, Khasar, Sachia, Goheer, M Anwar, Helms, Whitney S, Pan, Lili, Xu, Yuan, Fan, Jianghong, Leong, Ruby, Liu, Jiang, Yang, Yuching, Windsor, Katherine, Ou, Mei, Stephens, Olen, Oh, Byeongtaek, Reaman, Gregory H, Nair, Abhilasha, Shord, Stacy S, Bhatnagar, Vishal, Daniels, Selena R, Sickafuse, Sharon, Goldberg, Kirsten B, Theoret, Marc R, Pazdur, Richard, Singh, Harpreet

“…On April 10, 2020, the FDA approved selumetinib (KOSELUGO, AstraZeneca) for the treatment of pediatric patients 2 years of age and older with neurofibromatosis…”
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FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma by Barbato, Michael I, Nashed, Jeannette, Bradford, Diana, Ren, Yi, Khasar, Sachia, Miller, Claudia P, Zolnik, Banu S, Zhao, Hong, Li, Yangbing, Bi, Youwei, Shord, Stacy S, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Scepura, Barbara, Al-Matari, Raniya A, Pazdur, Richard, Kluetz, Paul G, Donoghue, Martha, Singh, Harpreet, Drezner, Nicole

“…On March 16, 2023, the FDA approved dabrafenib in combination with trametinib (Tafinlar, Mekinist; Novartis Pharmaceuticals Corporation) for the treatment of…”
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FDA Approval Summary: Sonidegib-Response by Shord, Stacy S, Casey, Denise, Zhao, Hong, Demko, Suzanne, Keegan, Patricia, Pazdur, Richard

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Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding by Cortes, Jorge E, Abruzzese, Elisabetta, Cardonick, Elyce H, Hernández-Díaz, Sonia, Gutierrez, Jamie, Sardegna, Mary S, Torres-Chavez, Erica, Dinatale, Miriam, Lerro, Catherine C, Gehrke, Brenda J, Shord, Stacy S, De Claro, R Angelo, Theoret, Marc R, DeMaria, Peter J, Norsworthy, Kelly J

“…Tyrosine kinase inhibitors (TKI) have improved the outcome and life expectancy of patients with chronic myeloid leukemia (CML). Patients are diagnosed with CML…”
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The Effect of Cyclophosphamide with and without Dexamethasone on Cytochrome P450 3A4 and 2B6 in Human Hepatocytes by LINDLEY, Celeste, HAMILTON, Geraldine, LECLUYSE, Edward L, MCCUNE, Jeannine S, FAUCETTE, Stephanie, SHORD, Stacy S, HAWKE, Roy L, HONGBING WANG, GILBERT, Darryl, JOLLEY, Summer, BINGFANG YAN

“…The purpose of this study was to characterize the concentration-response effects of cyclophosphamide (CPA) with and without dexamethasone (DEX; 10 μM) on the…”
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Paclitaxel alters the expression and specific activity of deoxycytidine kinase and cytidine deaminase in non-small cell lung cancer cell lines by Shord, Stacy S, Patel, Shitalben R

“…We observed that paclitaxel altered the pharmacokinetic properties of gemcitabine in patients with non-small cell lung cancer (NSCLC) and limited the…”
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FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs by Kluetz, Paul G, Keegan, Patricia, Demetri, George D, Thornton, Katherine, Sul, Joohee, Kim, Janice, Katzen, Harvey, Burke, Laurie Beth, Harvey, R Donald, Alebachew, Elleni, Agrawal, Sundeep, Nair, Abhilasha, Donoghue, Martha, Pierce, William F, Shord, Stacy S, Gao, Jennifer J, Pazdur, Richard

“…The FDA conducts independent reviews of scientific data obtained with investigational drug products to ensure that they are safe and effective. As a result of…”
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