Výsledky vyhledávání - "Ellen, Pinnow"

Trends in pediatric nonprescription analgesic/antipyretic exposures during the COVID-19 pandemic

Autor: Sara Karami, Cooma Asonye, Ellen Pinnow, Valerie Pratt, Lynda McCulley, Nana Dwumfour, Esther H. Zhou

Publikováno v: Clinical Toxicology. 61:190-199

To examine pediatric exposure trends involving selected nonprescription analgesics/antipyretics, before and during the COVID-19 pandemic. Using descriptive and interrupted time-series analyses, we assessed monthly United States poison center data inv

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5a56a1d6b33dbf1856a379635842fc96
https://doi.org/10.1080/15563650.2022.2158847

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Trend changes of national zolpidem users and exposure cases after FDA drug safety communications

Autor: Joann Lee, Gerald J. Dal Pan, Esther H. Zhou, Travis Ready, Ellen Pinnow, Daniel Bak, Zhou Feng

Publikováno v: Pharmacoepidemiology and Drug Safety. 30:1551-1559

Purpose To evaluate the impact of FDA's 2013 zolpidem Drug Safety Communications (DSCs), which recommended lowering the initial dose to mitigate drowsiness, on national estimates of zolpidem users and zolpidem exposure cases. Methods We analyzed tren

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bab0cffc53ab7d205ad4969850b549c7
https://doi.org/10.1002/pds.5344

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A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Autor: Aaron S. Kesselheim, Mayookha Mitra-Majumdar, Gerald J. Dal Pan, Joshua J. Gagne, Ellen Pinnow, Krista F. Huybrechts, Ameet Sarpatwari, Esther H. Zhou, Steven Woloshin, Gita A. Toyserkani, Claudia Manzo, Jerry Avorn, Kristyn Chin, Katsiaryna Bykov, Cynthia LaCivita, William Feldman

Publikováno v: Drug Safety. 44:743-751

Since 2007, the US Food and Drug Administration has had the authority to require risk evaluation and mitigation strategy (REMS) programs for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its r

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3322cd01d0e5a5dac5734aa6d1974214
https://doi.org/10.1007/s40264-021-01070-2

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Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities

Autor: Brendan Day, Sonja Brajovic, Sanae Cherkaoui, Gerald J. Dal Pan, Ellen Pinnow, Ilynn Bulatao, Manish Kalaria

Publikováno v: Clin Pharmacol Ther

We examined the relationship of regulatory and review characteristics to postmarketing safety-related regulatory actions for 61 new therapeutic biologics (NTBs) approved between October 1, 2002 and December 31, 2014. We also compared NTBs with small-

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::58ddbad88b5325cf4de5c335b6c2c2ce
https://doi.org/10.1002/cpt.1948

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Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration

Autor: David Croteau, Ellen Pinnow, Eileen Wu, Monica Muñoz, Ilynn Bulatao, Gerald Dal Pan

Publikováno v: Drug safety. 45(2)

New safety issues concerning US FDA-approved drugs are commonly communicated through safety-related labeling changes. Therefore, to optimize and refine postmarket safety surveillance strategies, it is important to comprehensively characterize the sou

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::890285779862cb19d54d78d43e0452db
https://pubmed.ncbi.nlm.nih.gov/35113347

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A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Autor: Ameet, Sarpatwari, Mayookha, Mitra-Majumdar, Katsiaryna, Bykov, Jerry, Avorn, Steven, Woloshin, Gita A, Toyserkani, Cynthia, LaCivita, Claudia, Manzo, Esther H, Zhou, Ellen, Pinnow, Gerald J, Dal Pan, Joshua J, Gagne, Krista F, Huybrechts, William B, Feldman, Kristyn, Chin, Aaron S, Kesselheim

Publikováno v: Drug safety. 44(7)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::a5a5fd92aee1de6d85e6bcfef8f60b2b
https://pubmed.ncbi.nlm.nih.gov/33904111

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The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes

Autor: Brendan Day, Sanae Cherkaoui, Ilynn Bulatao, Gerald J. Dal Pan, Ellen Pinnow, Sonja Brajovic, Manish Kalaria

Publikováno v: Clin Pharmacol Ther

We characterized the size of the premarket safety population for 278 small-molecule new molecular entities (NMEs) and 61 new therapeutic biologics (NTBs) approved by the US Food and Drug Administration (FDA) between October 1, 2002, and December 31,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ab4c72058374c7d8e2cc96ee926eb46
https://pubmed.ncbi.nlm.nih.gov/34057195

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FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes

Autor: Matthew Rosenberg, Morgan H. Romine, Esther H. Zhou, Sarah Sheehan, Jessica Burnell, Ellen Pinnow, Gerald J. Dal Pan

Publikováno v: Pharmacoepidemiology and drug safetyREFERENCES. 29(9)

Purpose Prior literature reviews have identified gaps in understanding of how postmarketing safety labeling changes and related FDA communications impact key clinical and behavioral outcomes. We conducted a review of newly published studies on this t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::471382d315c5e35e98541856d7c9158f
https://pubmed.ncbi.nlm.nih.gov/32790031

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Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014

Autor: Sonja Brajovic, Diane Marie M. St. George, Gerald J. Dal Pan, Laura L. Hungerford, Sania Amr, Søren M. Bentzen, Ellen Pinnow

Publikováno v: Clinical pharmacology and therapeutics. 104(2)

We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 y

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1be7c6df97fbea29cbc0bd7571ea3293
https://pubmed.ncbi.nlm.nih.gov/29266187

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