Advancing Drug Safety Through Prospective Pharmacovigilance.
Ther Innov Regul Sci. 2018.
PMID: 29714580
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Advancing Drug Safety Through Prospective Pharmacovigilance.
Ther Innov Regul Sci. 2018 Jul;52(4):400-402. doi: 10.1177/2168479018766887. Epub 2018 Apr 1.
Ther Innov Regul Sci. 2018.
PMID: 29714580
To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance must be a priority as the world's many regulatory systems build the capacity to harness electronic health information to improve health, c …
To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance …
Clinical perspectives in drug safety and adverse drug reactions.
Expert Rev Clin Pharmacol. 2008 Sep;1(5):695-705. doi: 10.1586/17512433.1.5.695.
Expert Rev Clin Pharmacol. 2008.
PMID: 24422739
This will include increased pressure on pharmaceutical companies to conduct postmarketing studies. Such an active/proactive approach, while maintaining focus on ADR detection, could also aim to extend knowledge of safety, such that emerging changes in risk-benefit d …
This will include increased pressure on pharmaceutical companies to conduct postmarketing studies. Such an active/proactive approach, …
Impact of aging on immune-related adverse events generated by anti-programmed death (ligand)PD-(L)1 therapies.
Eur J Cancer. 2020 Apr;129:71-79. doi: 10.1016/j.ejca.2020.01.013. Epub 2020 Mar 3.
Eur J Cancer. 2020.
PMID: 32143106
Weakness of the immune system, also called immunosenescence may occur with older age. The impact of aging on efficacy and safety of immune checkpoint blockers, such as anti-programmed death (ligand) PD-(L)1, remains undetermined. This study aims to evaluate the incidence o …
Weakness of the immune system, also called immunosenescence may occur with older age. The impact of aging on efficacy and safety of i …
Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Mapping.
Drug Saf. 2017 Sep;40(9):823-834. doi: 10.1007/s40264-017-0551-0.
Drug Saf. 2017.
PMID: 28597251
Review.
The Newcastle-Ottawa Scale and appropriate guidelines from the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) were used to assess the quality of included studies. RESULTS: After screening 832 articles, …
The Newcastle-Ottawa Scale and appropriate guidelines from the International Society for Pharmacoepidemiology (ISPE) and the International S …
Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice.
Eur J Nucl Med Mol Imaging. 2019 May;46(5):1102-1110. doi: 10.1007/s00259-019-4261-y. Epub 2019 Jan 12.
Eur J Nucl Med Mol Imaging. 2019.
PMID: 30637501
Free PMC article.
Clinical Trial.
PURPOSE: REASSURE is a global, prospective, non-interventional study to assess long-term safety of radium-223 in patients with bone metastatic castration-resistant prostate cancer. ...CONCLUSIONS: The short-term safety profile of radium-223 in routine clinica …
PURPOSE: REASSURE is a global, prospective, non-interventional study to assess long-term safety of radium-223 in patients with …
Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.
Drug Saf. 2013 Dec;36(12):1129-49. doi: 10.1007/s40264-013-0113-z.
Drug Saf. 2013.
PMID: 24092596
Free PMC article.
The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. ...The members of the PROSPER Consortium therefore direct this PRO-AE guidance to multiple stak …
The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better i …
Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting risks earlier.
Eur J Clin Pharmacol. 2014 Jun;70(6):745-56. doi: 10.1007/s00228-014-1670-5. Epub 2014 Apr 3.
Eur J Clin Pharmacol. 2014.
PMID: 24691786
METHODS: Four major regulatory authorities were searched for their issued safety alerts supported by longitudinal, comparative studies (experimentals and/or observationals). The random-effects model was used to pooled odds ratios (OR) over time by including …
METHODS: Four major regulatory authorities were searched for their issued safety alerts supported by longitudinal, comparative …
Current Pharmacotherapy Does Not Improve Severity of Hypoactive Delirium in Patients with Advanced Cancer: Pharmacological Audit Study of Safety and Efficacy in Real World (Phase-R).
Oncologist. 2019 Jul;24(7):e574-e582. doi: 10.1634/theoncologist.2018-0242. Epub 2019 Jan 4.
Oncologist. 2019.
PMID: 30610009
Free PMC article.
This was a pharmacovigilance study characterized by prospective registries and systematic data-recording using internet technology, conducted among 38 palliative care teams and/or units. ...IMPLICATIONS FOR PRACTICE: Delirium is common among patients with advance …
This was a pharmacovigilance study characterized by prospective registries and systematic data-recording using internet techno …
Safety profile of repeated rituximab cycles in unselected rheumatoid arthritis patients: a long-term, prospective real-life study.
Clin Exp Rheumatol. 2016 Sep-Oct;34(5):893-900. Epub 2016 Jul 5.
Clin Exp Rheumatol. 2016.
PMID: 27383049
Free article.
METHODS: This was a multicentre (17 Greek Rheumatology sites), prospective, long-term, pharmacovigilance study of patients with moderate to severe RA and an inadequate response or intolerance to 1 anti-tumour necrosis factor (TNF) agents. ...CONCLUSIONS: Long-term R …
METHODS: This was a multicentre (17 Greek Rheumatology sites), prospective, long-term, pharmacovigilance study of patients wit …
Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice.
Intest Res. 2019 Oct;17(4):504-515. doi: 10.5217/ir.2019.00030. Epub 2019 Aug 23.
Intest Res. 2019.
PMID: 31422647
Free PMC article.
BACKGROUND/AIMS: An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease. METHODS: Patients were prospectively enrolled between Nov …
BACKGROUND/AIMS: An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its sa …
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