level: DESIGN FACTORS
Questions and Answers List
level questions: DESIGN FACTORS
| Question | Answer |
|---|---|
| Matrixing designs can be applied to strengths with identical or closely related formulations, such as: | (1) capsules of different strengths made with different fill plug sizes from the same powder blend (2) tablets of different strengths manufactured by compressing varying amounts of the same granulation (3) oral solutions of different strengths with formulations that differ only in minor excipients (e.g., colorants or flavorings) |
| Other design factors that can be matrixed include: | (1) batches made by using the same process and equipment (2) container sizes and/or fills in the same container closure system. |
| Design Factors can also be applied to different STRENGTHS where/to: | (1) the relative amounts of drug substance and excipients change (2) different excipients are used (3) different container closure systems |
| POTENTIAL RISK of matrixing design on factors other than time points | 1 less precision in shelf life estimation 2 yields a shorter shelf life than the corresponding full design |