Abstract

Big data analysis has enhanced its demand nowadays in various sectors of health-care including pharmacovigilance. The exact definition of big data is not known to many people though it is routinely used by them. Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease, drug monitoring, etc. This data are usually collected from doctors and pharmacists in a health-care facility. Analysis of big data in pharmacovigilance is useful for early raising of safety alerts, line listing them for signal detection of drugs and vaccines, and also for their validation. The present paper is intended to discuss big data analytics in pharmacovigilance focusing on global prospect and domestic country-India.

Highlights

  • Big data is marked and cited as keyword nowadays in various sectors of health care including pharmacovigilance (Pv)

  • Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease and drug monitoring [1]

  • Future directions which will overcome the current limitations of big data analytics in Pv include improvement inconsistency among data sources, validation of utilizing data sources, the establishment of standards for signal detection, application of an integrative approach to signal detection, improvement of data mining software and tools, application of data mining to other product safety and regulatory issues [44]

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Summary

INTRODUCTION

Big data is marked and cited as keyword nowadays in various sectors of health care including pharmacovigilance (Pv). Computer accesses data and use it to automatically learn and improve by experience [21] It is useful in multiple domains of pharmacovigilance for the elimination of human error and standardization of processes [22] This is modeled according to the neuronal structure of the mammalian brain In this method, the computer translates texts from one language to another This aids the computer to understand human language and language‐related tasks This method improves accuracy by understanding the searcher’s intent and contextual meaning of terms Blocks are a list of records that are linked and secured using cryptography It is the process of extracting and transforming relevant information from unstructured data which can be used for further analysis and process This process transforms data into a written or narrative form and the output is generated from structured data It is the software that operates on behalf of users by employing some knowledge This process utilizes software to perform traditional manual activities containing high volume and repetitive processes involving structured data It is the automation process within the desktop to provide guidance or assistance to human resources on demand It is an advanced analytical process that uses current and historical data to draw inferences. Concerning privacy and confidentiality, much work is needed in terms of formulating guidelines to help drug developers understand the nature and extent of big data that would be deemed admissible in the drug approval process [40,41]

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CONCLUSION
27. Big Data Approaches in Pharmacovigilance
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