ICH Q1A (STABILITY TESTING OF NEW DRUG SUBSTANCE & PRODUCT)
ICH Q1B (PHOTOSTABILITY TESTING FOR NEW DRUG SUBSTANCE & PRODUCT)
ICHQ1C (STABILITY TESTING OF NEW DOSAGE FORM)
ICH Q1E (EVOLUTION OF STABILITY DATA)
ICHQ3A (IMPURITY IN NEW DRUG SUBSTANCE)
ICH Q3B (IMPURITY IN NEW DRUG PRODUCT)
ICH Q5C ( STABILITY TESTING OF BIOTECHNONOLOGICAL/ BIOLOGICAL PRODUCT)
Friday, March 5, 2010
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If shelf life can be set at the 95% lower confidence limit for the sample mean, then 50% of the population would be <95% of the acceptance criteria.
ReplyDeleteIs that correct?