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09. Orphan Drug Designations...
Editorial Archive

Orphan Drug Designations – Are the EMA and FDA looking for the same Information?

Whilst working on a recent European application for an Orphan Drug Designation (ODD) for a rare neurological condition that was being made to the EMA, …

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08. Common Pitfalls of...
Editorial Archive

Common Pitfalls of RECIST 1.1 Application in Clinical Trials

Revised Response Evaluation Criteria in Solid Tumours (RECIST 1.1) came into effect in 2009 in order to address the issues and limitations of RECIST 1.0. …

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Editorial Archive

Supplier Qualification: A Review

It is a GMP requirement to certify the vendor to deliver high quality and safe medicines, and to prevent recalls, deaths, adverse events, and serious …

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01. Device Integration in Clinical...
Editorial Archive

Device Integration in Clinical Research – A Fad or the Future?

Nowhere is the advance of technology felt more acutely than in the field of healthcare and clinical research. The very future of the industry relies …

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