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OCD - Rushikesh Laxman Tamhane - 29 Aug 2024

Precision studies for method validation ich q2r2

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rushitamhane19
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18 views2 pages

OCD - Rushikesh Laxman Tamhane - 29 Aug 2024

Precision studies for method validation ich q2r2

Uploaded by

rushitamhane19
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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PRECISION

Precision should be investigated using homogeneous, authentic samples or artificially prepared samples (e.g., matrix mixtures
spiked with relevant amounts of the analyte in question)
If a homogeneous sample is not available, then artificially prepared samples or a sample solution can be used

INTERMEDIATE PRECISION
Minimum of 9 determinations
• Depends on the circumstances under which the procedure is
covering the reportable range
intended to be used
for the procedure
• Like different days, environmental conditions, analysts and
(3 conc. /3 replicates each)
equipment, as relevant

REPETABILITY • Variations tested should be based on ICH Q14


REPRODUCIBILITY
• Reproducibility is assessed by means of an inter-laboratory trial.
• Not required for regulatory submission but should be considered in
A minimum of 6
determinations at 100% of cases of standardization of an analytical procedure, for inclusion in
the test concentration.
pharmacopoeias

Rushikesh Laxman Tamhane OCD of Alpha Darn Date : 29 Aug 2024


LINEARITY
Recommended data
• The SD, RSD & confidence interval should be reported for each type of precision investigated and be compatible with the specification limits.
• Additionally, for multivariate analytical procedures, the routine metrics of RMSEP encompass accuracy and precision.

Combined approaches for accuracy and precision


• For separate evaluation of accuracy and precision consider their total impact by assessing against a combined performance criterion
• The approach should be reflective of the individual criteria that would have been established for accuracy and precision
• Data generated during development may help determine the best approach and refine appropriate performance criteria to which combined
accuracy and precision are compared
• Combined accuracy and precision can be evaluated by use of a prediction interval (to assess the probability that the next reportable value falls
within the acceptable range) or a tolerance interval (to assess the proportion of all future reportable values that will fall within the acceptable
range)
Recommended Data
• If a combined performance criterion is chosen, results should be reported as combined value to provide appropriate overall knowledge of the
suitability of the analytical procedure
• If relevant, the individual results for accuracy and precision should be provided as supplemental information, The approach used should be
described.
Rushikesh Laxman Tamhane OCD of Alpha Darn Date : 29 Aug 2024

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