Clinical Trials and Accreditation

Clinical trials and accreditations

SMAC achieved GCP accreditation in 2018, allowing us to run clinical trials. All our methods are validated according to GCP standards.

Our validation protocols include:

  • Calibration range
  • Lower limit of quantitation (LLOQ)
  • Limit of detection (LOD)
  • Upper limit of quantitation (ULOQ)
  • Carry-over
  • Accuracy across calibration range
  • Precision across calibration range
  • Absolute Recovery
  • Inter-day reproducibility
  • Intra-day reproducibility
  • Matrix Effects
  • Stability

Validation References:

  1. J.W. Honour, Development and validation of a quantitative assay based on tandem mass spectrometry, Annals of Clinical Biochemistry 48 (2011) 97–111.
  2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Bioanalytical Method Evaluation, Guidance for Industry, 2018
  3. B.J. Linnet K, Selection and analytical evaluation of methods – with statistical techniques., in: A.E. Burtis CA, Bruns DE (Ed.) Tietz textbook of clinical chemistry and molecular diagnostics, Saunders, St. Louis, 2006, pp. 353-407.

Recent clinical trials