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Table 2 Examples of Clinical Lean Stability Strategies

From: AAPS Workshop: accelerating pharmaceutical development through predictive stability approaches, April 4–5, 2016

No. Strategy Comments
1 Apply DS stability data (solely) to simplified/DS-based dosage forms, e.g. DS in a bottle or capsule Justification included in the CTA (also reference section S.7 in P.8)
2 Assign initial DS review period of 18 M based on one week 70 °C/75%RH data Commitment for ‘formal’ program included in CTA
3 Use ASAP to determine packaging, long-term storage conditions, to set the initial use period (e.g. 12 month) Data, conclusions and commitment for ‘formal’ program included in CTA
4 Use ASAP to assist in assessing whether a change in DS or DP process, composition or packaging affects stability, and thus need for additional stability program Inclusion in CTA is case dependent
5 Reduce testing protocol (e.g. time points, tests, conditions) based on supportive data Inclusion of explicit justification in the CTA is case dependent
6 Eliminate DS assay testing if it is the same lot as the reference standard Justification included in the CTA