Friday, March 5, 2010

ICH guide line For stability study

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)
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1 comment:

  1. JeremyNovember 5, 2010 at 8:30 AM

    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.

    Is that correct?

    ReplyDelete

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