Module 5 Presentations

05/07/2024

Ketek case - study 3014 (4)

Till June 2006

• 23 cases of acute severe liver injury and 12 cases of acute liver failure , 4 of them fatal , had been linked to Ketek • By the end of 2006, Ketek had been implicated in 53 cases of hepatotoxic effects February 12, 2007 • The withdrawal of approval for two indications, acute bacterial sinusitis and acute exacerbation of chronic bronchitis, for which Ketek’s efficacy had never been demonstrated

The Organisation for Professionals in Regulatory Affairs

Ketek case -study 3014

75

We covered

• History of Good Clinical Practices and development of legislation • Ethical principals of clinical research • ICH GCP • Quality and audits in clinical trials

The Organisation for Professionals in Regulatory Affairs

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