July 2018

IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction - Focus on CYP3A4 mRNA

Author: Scott Hickman, Dr. Brian Ogilvie Posted: 13 July 2018

Sekisui XenoTech made contributions to the June 29th paper entitled, “Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA in vitro response thresholds, variability, and clinical relevance.” This paper, prepared by the IQ Induction Working Group of The International Consortium for Innovation & Quality in Pharmaceutical Development (IQ) and found in the journal Drug Metabolism and Disposition, provides recommendations that do not supersede any regulatory guidance at this time, but do guide pharmaceutical companies on how to conduct CYP induction studies...

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New Guidance on Bioanalytical Services

Author: Seema Muranjan, Scott Hickman Posted: 06 July 2018

On May 24, 2018, the US Food and Drug Administration (FDA) released new Bioanalytical Method Validation Guidance for Industry. Sekisui XenoTech’s approach to method validation is based on this bioanalytical guidance document, along with the most recent European Medicines Agency (EMA) 2011 Guideline on bioanalytical method validation...

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