Výsledky vyhledávání - "Robert Bwire"

Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention

Autor: Nancy A. Brandenburg, Paul Sheehan, John Freeman, Robert Bwire, Florence Houn, Jerome B. Zeldis

Publikováno v: Drug Safety

Introduction The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4d82876361508671e6e68265c334f7a8
https://doi.org/10.1007/s40264-016-0501-2

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Global Implications of the EU’s Pharmacovigilance System Master File Requirements: Newly Developed Decision Trees to Distinguish Different Study Types

Autor: Nancy Walsh, Robert Bwire, Stefan T. Kaehler, Neil Minton, John Freeman, David Gillen

Publikováno v: Pharmaceutical Medicine. 29:323-329

In Europe, a new guideline on good pharmacovigilance practices–Module II: Pharmacovigilance system master file (PSMF)—was issued, and initially came into effect on 2 July 2012, with revision on 12 April 2013. The guideline describes the PSMF, whi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c102f2b1c3be1d6da324e88633ce21b8
https://doi.org/10.1007/s40290-015-0116-4

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Teratogenic Drugs and Risk Management: An Implementation Assessment

Autor: Robert Bwire, John Freeman, Paul Sheehan, Florence Houn, Jay Backstrom

Publikováno v: Therapeutic Innovation & Regulatory Science. 48:420-427

About half of all pregnant women are prescribed medication during their pregnancy, including drugs with teratogenic potential. There is a need to manage teratogenic risk and prevent fetal harm. In the US, risk management strategies may range from pro

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5d496ac1ccccd2d483ab3614a87881e6
https://doi.org/10.1177/2168479013516776

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False-positive pregnancy tests in females of reproductive potential receiving lenalidomide in the United States

Autor: Damien Hirsch, Paul Sheehan, Carmen Castaneda, Robert Bwire, Melinda Mezo, Neil Minton, May L. Chan-Liston, Robin McWilliams, John Freeman, Lisa Phillips

Publikováno v: Leukemia & Lymphoma. 59:1025-1026

Lenalidomide is approved in the United States for various indications, including multiple myeloma (MM), myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality and relapsed, ...

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7229f9a00c1951e311af788f531a5bf7
https://doi.org/10.1080/10428194.2017.1361030

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Managing the teratogenic risk of thalidomide and lenalidomide: an industry perspective

Autor: Robert Bwire, John Freeman, Florence Houn

Publikováno v: Expert Opinion on Drug Safety. 10:3-8

Celgene has developed and operated pregnancy prevention programs since 1998 with the first approval of thalidomide in the US. With the development and marketing of lenalidomide, an analog of thalidomide, the company further advanced its risk manageme

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::795a744bd4d92a8a339b13fae09a4fba
https://doi.org/10.1517/14740338.2011.527331

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The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals

Autor: Stefan T. Kaehler, Michelle Di Vito-Smith, Richard Pilot, Nicolette Bester, Theresa McGarry, Robert Bwire, Michael Riffkin

Publikováno v: Advances in Therapy

Introduction Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b025aac3f167a16c4666fb25e096236a
https://pubmed.ncbi.nlm.nih.gov/26801772

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Finding patients eligible for antiretroviral therapy using TB services as entry point for HIV treatment

Autor: Nico Nagelkerke, Martien W. Borgdorff, Robert Bwire

Publikováno v: Tropical medicine & international health, 11(10), 1567-1575. Wiley-Blackwell

OBJECTIVE: To estimate the proportion of antiretroviral therapy (ART) eligible adults (15-49 years) with tuberculosis potentially identifiable through tuberculosis services using a CD4 count below 350 cells/mm3 as cut-off value for ART initiation. ME

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4b204d6beee01fa61199340c5b0d6831
https://doi.org/10.1111/j.1365-3156.2006.01712.x

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Venous thromboembolism in myelodysplastic syndrome patients receiving lenalidomide: results from postmarketing surveillance and data mining techniques

Autor: Jerome B. Zeldis, John Freeman, Maria Luisa Salomon, Robert Bwire, Xionghu Yang, Nancy A. Brandenburg, Robert Knight

Publikováno v: Clinical drug investigation. 29(3)

Background and objectives: Multiple myeloma treatment with lenalidomide-based regimens is associated with risk of venous thromboembolism (VTE), particularly during concomitant use with erythropoiesis-stimulating agents (ESAs). The risk of VTE in myel

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::04fa03d91248a601256b8c9961cb9348
https://pubmed.ncbi.nlm.nih.gov/19243209

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