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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
It is the design of a stability schedule such that only samples on the extremes of certain design factors (e.g., strength, container size and/or fill) are tested at all time points as in a full design.	BRACKETING
Bracketing can be applied to studies with multiple STRENGTHS of identical or closely related formulations. Examples include but are not limited to: __	(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, flavorings)
Bracketing can be applied to studies with multiple __ where the relative amounts of drug substance and excipients change in a formulation.	Strengths
Bracketing can be applied to studies of the same __ where either container size or fill varies while the other remains constant.	Container Closure System
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. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point	Matrixing
1 A matrixing design should be __ so that each combination of factors is tested to the same extent over the intended duration of the study and through the last time point prior to submission 2 All selected factor combinations should be tested at the __ time points 3 For matrixing at an accelerated or intermediate storage condition, __ should be taken to ensure testing occurs at a minimum of three time points, including initial and final, for each selected combination of factors	1 balanced as far as possible 2 initial and final 3 care
is applicable if the supporting data indicate predictable product stability	matrixing design
__ appropriate when the supporting data exhibit only small variability	Matrixing