Ther Innov Regul Sci
Development of a Computer-Assisted Adverse Drug Events Alarm and Assessment System for Hospital Inpatients in China.
Chen C, Jia W, Guo D, Zhu M, Xu Y, Wang X, Wang D, Wang W, Tang Z
Computerized detection is a promising method for monitoring adverse drug events (ADEs); however, this method is currently in its infancy and is a new ...
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Source: PubMed
Ther Innov Regul Sci
Statistical Methods for Clinical Study Site Selection.
Xu J, Huang L, Yao Z, Xu Z, Zalkikar J, Tiwari R
The US Food and Drug Administration conducts on-site inspections and data audits through Bioresearch Monitoring program for assurance of the quality a ...
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Source: PubMed
Ther Innov Regul Sci
Adaptive Design: A Review of the Technical, Statistical, and Regulatory Aspects of Implementation in a Clinical Trial.
Cerqueira FP, Jesus AMC, Cotrim MD
In an adaptive trial, the researcher may have the option of responding to interim safety and efficacy data in a number of ways, including narrowing th ...
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Source: PubMed
Drug Saf 2020 Feb 01
Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations.
Caster O, Aoki Y, Gattepaille LM, Grundmark B
Uncovering safety signals through the collection and assessment of individual case reports remains a core pharmacovigilance activity. Despite the wide ...
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Source: PubMed
Int J Clin Pharm 2020 Jan 31
Comparison of drug survival between infliximab and adalimumab in inflammatory bowel disease.
Gil-Candel M, Gascón-Cánovas JJ, Urbieta-Sanz E, Rentero-Redondo L, Onteniente-Candela M, Iniesta-Navalón C
Background Conventional therapy of inflammatory bowel disease with traditional immunosuppressant medication is increasingly being replaced by biologic ...
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Source: PubMed
