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Drug Counterfeiting

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Implementing global standards to ensure end‑to‑end FMD compliance

1 July 2019 | By

Effective drug serialisation and identification is essential for improving the safety of medicines and combatting counterfeits. The Falsified Medicines Directive’s new requirements promise to crack down on the impacts of unsafe drugs. Neil Piper discusses the human cost of falsified medicines and how companies need to increase traceability of individual…

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Identification of peptides and proteins in suspected illegal medicinal products using MALDI-TOF-MS

26 February 2019 | By , ,

Matrix-assisted laser desorption/ionisation (MALDI) time-of-flight (TOF) mass spectrometry (MS) has proven to be an excellent technique for identification of illegally distributed peptides and proteins for human use. The identification of proteins is mainly based on peptide mass fingerprinting (PMF) – ie, the bottom-up approach – while the small proteins and…

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Recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines

2 January 2019 | By , , , , , , , ,

Quality medicines are essential to any healthcare system and are the final goal of any pharmaceutical manufacturer. Unfortunately, as stated recently by the World Health Organization (WHO), one in 10 medical products circulating in low and middle-income countries is either substandard or falsified (SF products).1 Although the exact prevalence of…

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Understanding the complexities of global serialisation & traceability regulations

18 September 2018 | By Clarivate Analytics

In 2017 the WHO estimated that the counterfeit drug market represents around 10-15 per cent of the pharmaceutical market worldwide, with an estimated $200bn revenue per year. Worldwide there were 3,509 pharmaceutical crime incidents in 2017, which represents an 11% increase from 2016. Most falsified medicines that reach the market…