Non-Regulatory level studies
At early ADME/PK testing, M-Scan employs generic analytical methods to minimise time and costs with the aim of providing data at an appropriate quality level to evaluate PK characteristics and determine PK/PD correlation. A throughput of 8-12 new chemical entities (NCEs) tested for microsome stability / day is achieved. A throughput of 30 - 60 samples / day of rat plasma / CSF for early pharmacokinetic assessment is achieved.
Regulatory Level studies
For fully regulated studies, a throughput of 90-110 PK points / day / technician is achieved.
Quality Systems
Both IUPAC and BARQA (British Association for Research in Quality Assurance) recommendations are followed. For regulatory level studies, our laboratories are GLP and cGMP compliant and inspected.
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M-Scan Brochure: Biotechnology and Pharmaceutical Analysis (8pp.)