Analytical Support on Drug-Drug Interaction Evaluation for your Clinical Development

Sumika Chemical Analysis Service, Ltd. (SCAS) provides comprehensive analytical services for drug–drug interaction (DDI) studies, covering both perpetrator and victim drugs. In addition, we provide endogenous biomarker measurement services, which are increasingly recognized as valuable tools for evaluating drug metabolism and transporter activity in DDI risk assessment.

The ICH M12 guideline (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – M12: Guideline for Drug Interaction Studies) was internationally adopted on May 21, 2024, followed by Japanese "Guidelines for Drug Interaction Studies," which was issued on November 27, 2024 by the Ministry of Health, Labour and Welfare. These guidelines highlight the use of endogenous biomarkers as a novel approach in DDI evaluation. These biomarkers are endogenous compounds that reflect the activity of specific enzymes or transporters

• For over three decades, we have developed highly sensitive LC-MS/MS methods, enabling accurate quantification of drug concentrations in biological samples, even in the presence of concomitant medications.
• We have extensive experience in bioanalysis of approved drugs co-administered in complex biological samples. We can respond to your requests for a wide variety of co-administered drugs with validated analytical methods. Please contact us regarding the analyses of other compounds.
• We have established and validated a plasma assay for coproporphyrin I (CP1), an endogenous biomarker for hepatic OATP1B (Organic Anion Transporting Polypeptide 1B) inhibition. We also validated methods for other endogenous biomarkers suitable for DDI assessment.

• Pharmaceuticals and Medical Devices Agency (PMDA), "Guidelines for Drug Interaction Studies," No. 1127-2, November 27, 2024. [https://www.pmda.go.jp/files/000272132.pdf] (accessed November 28, 2025)
• ICH, "ICH M12: Guideline for Drug Interaction Studies," [https://www.pmda.go.jp/int-activities/int-harmony/ich/0101.html] (accessed November 28, 2025)

A detailed list of analytical methods and validation data for typical substrates and inhibitors for CYP isoforms and transporters, including plasma CP1, is available on a secured web page.

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For the compounds listed in the blue cells above, their analytical methods have already been validated in terms of linearity and reproducibility, and have been used for the analyses of actual biological samples.

(As of October 2025)