A5032336087- Pharmaceutical Quality and Counterfeiting
- Pharmaceutical Economics and Policy
- Statistical and Computational Modeling
- Identification and Quantification in Food
- Intellectual Property and Patents
Health Sciences Authority
2021-2023
Substandard medicines are that fail to meet their quality standards and/or specifications. can lead serious safety issues affecting public health. With the increasing number of pharmaceuticals and complexity pharmaceutical manufacturing supply chain, monitoring for substandard via manual environmental scanning be laborious time consuming.A web crawler was developed automatically detect extract alerts on published Internet by regulatory agencies. The crawled data were labelled as related or...
Monitoring for substandard medicines by regulatory agencies is a key post-market surveillance activity. It important to prioritise critical product defects review ensure that prompt risk mitigation actions are taken.A impact prioritisation model (RISMED) with 11 factors considering the seriousness and extent of defect was developed. The generated an overall score categorised cases into high, medium or low impact. further developed statistical scoring (stat-RISMED) using multivariate logistic...