Stability testing matrixing design

Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products... 

ICH QID Bracketing and matrixing designs for stability testing of drug substances and drug products Step 5 (2002)... 

Matrixing design [10] may involve elimination of some stability sample pull time points to achieve reduced testing strategy. For example, a one-half reduction in time points eliminates one in every two time points from full study design, and one-third reduction eliminates one in every three time points. However, such a scenario must include full testing at initial, 12-month, and final time points under a 36-month shelf life study [10]. 

Experiment 3. Long-term matrix storage stability. Test for the designated temperature, i.e., -20 °C or -70 °C to cover the time of sample analysis. 

Matrixing is the design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations would be tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations would be tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and possibly, in some cases, different container closure systems. 

P. Helboe, New designs for stability testing programs Matrix or factorial designs. Authorities viewpoint on the predictive value of such studies, Drug Inform. J. 26, 629-634(1992). 

International Conference on Harmonization (2002) QID Bracketing and matrixing designs for stability testing of drug substances and drug products EU adopted by CPMP, February 2002, CPMP/ICH/4104/00 MHLW adopted on July 31, 2002 as PFSB/ELD notification No. 

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