IVIVC
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An In-vitro in-vivo correlation (IVIVC) has been defined by the Food and Drug Administration (FDA) as “a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response”.
Generally, the in-vitro property is the rate or extent of drug dissolution or release while the in-vivo response is the plasma drug concentration or amount of drug absorbed. The United States Pharmacopoeia (USP) also defines IVIVC as “the establishment of a relationship between a biological property, or a parameter derived from a biological property produced from a dosage form, and a physicochemical property of the same dosage form”.
Typically, the parameter derived from the biological property is AUC or Cmax , while the physicochemical property is the in vitro dissolution profile.
The main role's of IVIVC are:
- The first and main role of establishing IVIVC is to use dissolution test as a surrogate for human studies.
- Supports and / or validates the use of dissolution methods and specifications.
- Assists in quality control during manufacturing and selecting appropriate formulations
References
- The United Stated Pharmacopeia. (23rd ed.). (1995). In Vitro and In Vivo Evaluation of Dosage form < 1088>. 1824-1929. Rockville, MD.
- Shargel, L., and Yu, A. B. C. (1993). Applied Biopharmaceutics and Pharmacokinetics. East Norwark, Connecticut: Appleton & Lange.
- Drewe, J., and Guitard, P. (1993). In vitro-in vivo correlation for modified-release formulations. Journal of Pharmaceutical Sciences. 82(2), 132-137.
