[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].
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 method allows calculation of release limits of potency of any dosage form and applies to any parameter for which the rate of change with time is predictably uniform and linear. Assurance is then provided at 95% confidence level that any lot showing a mean release assay result within the calculated release limits will remain within registered limits at any subsequent time within its shelf-life. On the basis of real quality profiles including dozens of lots, the authors explains that the use of this statistical method leads to an efficient retrospective validation technic by means of chemical analysis.
Nivet
J M
JM
Laboratoires UPJOHN, Val-de-Reuil.
D004348:Drug Labeling / Q000706:statistics & numerical data*; D010599:Pharmacokinetics; D010600:Pharmacology