Professional Documents
Culture Documents
Evaluation For Stability Data Q1E: Sumie Yoshioka, Ph. D. MHLW National Institute of Health Sciences
Evaluation For Stability Data Q1E: Sumie Yoshioka, Ph. D. MHLW National Institute of Health Sciences
Q1E
Q1E contains
examples of statistical approaches to
stability data analysis
z Extrapolation
toto extend retest period/shelf
life
z Statistical approaches
recommended in the guideline
No Significant Yes
change
Accelerated condition
Where no significant change occurs
at accelerated condition
No Significant Yes
change
Intermediate condition
No Amenable? Yes
Performed?
Statistical analysis
No Yes
Available?
Supporting data
Four outcomes
passing through crossroads
for Room Temperature Storage
12 month extension
6 month extension
3 month extension
No extension
Outcome 1 12 month extension
accelerated data show
no significant change
accelerated data & long-term data
little or no change
little or no variability
Outcome 4 no extension
significant change
at accelerated condition
at intermediate condition
Statistical analysis
longer retest period/shelf life
amenable? No
performed? 6 month extension
amenable? No
performed? 3 month extension
Where
zsignificant change
at accelerated & intermediate conditions
zvariability in long-term data
115
Assay (% of Label Claim)
110
105
Raw Data
100 Upper confidence limit
95 Lower confidence limit
Regression line
90
Upper acceptance
85 criterion: 105
Lower acceptance
80 criterion: 95
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48
Time Point (Months)
Statistical approaches
for determining whether data from different
batches/factor combinations can be pooled