[Statistic determination of release limits of a finished product active principle compared to drug specification at peremption and eventually at the end of its after reconstitution].

  • Julien Nivet
  • Published 1996 in Annales pharmaceutiques francaises


At manufacturing, finished dosage forms must meet the 75/318/EEC Directive particularly the criteria defining the potency registered limits i.e. +/- 5% variation of their nominal contents in general except some cases where sound justification can be provided on the basis of experimental results obtained at 95% confidence level. The described statistical… (More)


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