The ICH Guideline for Stability Testing—What Matrixing does it Permit?

@article{Pack1998TheIG,
  title={The ICH Guideline for Stability Testing—What Matrixing does it Permit?},
  author={David J. Pack},
  journal={Therapeutic Innovation & Regulatory Science},
  year={1998},
  volume={32},
  pages={561 - 567}
}
This paper examines the allowance for matrix designs in stability testing included in the 1993 International Conference on Harmonization (ICH) international guideline for stability testing of new drug substances and products. The paper first provides some concept of different types of statistical designs for stability testing, including the general concepts of bracket and matrix designs. Secondly, it restates the guideline's definition of matrixing and the associated definition of a drug… CONTINUE READING

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