BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials

“BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials”

By J. Kirk Smith, Ph.D., Sr. Director, Regulatory and Quality Systems and John P. Pirro, Vice President and Chief Operating Office

Over the course of the last year, a pharmaceutical industry consortium has been leading the initiative to develop an industry acceptable guideline applicable to standardizing acceptable laboratory and quality management practices for bioanalytical studies supporting clinical trials. Participating in the initiative are representatives from a number of top worldwide pharmaceutical and generic companies.

A white paper from Synomics Pharma, titled “BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials”, describes the BQSI, an initiative born out of the industry-wide recognition that neither the US FDA or EMEA regulation nor ICH harmonized guidelines address laboratory analysis in support of clinical trials.

To download the paper and the latest version of the Bioanalytical Quality Standards Initiative (BQSI) Guidance Document, please fill out the form below.












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