Výsledky vyhledávání - "Gerlie Gieser"

Data from FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia

Autor: Richard Pazdur, Gideon M. Blumenthal, Ann T. Farrell, Kirsten B. Goldberg, Jiang Liu, Anamitro Banerjee, Christopher M. Sheth, Stacy S. Shord, Yuan Li Shen, Donna Przepiorka, David A. Bateman, Gerlie Gieser, Kumar G. Janoria, Wentao Fu, Paresma Patel, Michael L. Manning, Liang Li, Xin Gao, Aviva C. Krauss

On August 3, 2017, the FDA granted regular approval to Vyxeos (also known as CPX-351; Jazz Pharmaceuticals), a liposomal formulation of daunorubicin and cytarabine in a fixed combination, for the treatment of adults with newly diagnosed therapy-relat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::54674ded12a4d242af56ef0583b02f7c
https://doi.org/10.1158/1078-0432.c.6528362

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Supplemental Table S1 from FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia

Supplemental Table S1: Grouped Terms for Adverse Reactions on Study 301

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2a4c8d39e6c98e8ee1b0d9194c689465
https://doi.org/10.1158/1078-0432.22472897.v1

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Supplemental Table S2 from FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia

Supplemental Table 2: Prolonged Cytopenia on Study 301

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1da6dffa5a43ed01333b3429062bf641
https://doi.org/10.1158/1078-0432.22472894

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FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non-Small Cell Lung Cancer Following Crizotinib

Autor: Amy E. McKee, Gina Davis, Kimberly Ringgold, Hong Zhao, Olen Stephens, Erin Larkins, Jingyu Yu, Whitney Helms, Huanyu Chen, Richard Pazdur, Kun He, Eias Zahalka, Gideon M. Blumenthal, Gerlie Gieser, Rajiv Agarwal, Patricia Keegan, Stacy Shifflett Shord

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research. 22(21)

On December 11, 2015, the FDA granted accelerated approval to alectinib (Alecensa; Genentech) for the treatment of patients with anaplastic lymphoma receptor tyrosine kinase (ALK)-positive, metastatic non–small cell lung cancer (NSCLC) who have pro

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5a9727fcf3b427ce893758f7c63dd0e8
https://pubmed.ncbi.nlm.nih.gov/27413075

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Improving pediatric dosing through pediatric initiatives: what we have learned

Autor: Rosemary Roberts, Debbie Avant, Terrie Crescenzi, Hari Cheryl Sachs, Ramana S. Uppoor, Arzu Selen, Chandra S. Chaurasia, Dianne Murphy, Peter I D Lee, Jennifer Di Giacinto, Shiew-Mei Huang, Gerlie Gieser, Shirley Murphy, Lisa Mathis, Sandra Suarez, William J. Rodriguez, Veneeta Tandon

Publikováno v: Pediatrics. 121(3)

OBJECTIVE. The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the drug labeling. METHODS. We reviewed the pediatric studies for 108 products subm

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9226b32aad5e634e0da54b9a96bb92dd
https://pubmed.ncbi.nlm.nih.gov/18310202

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