In-Vitro and In-Vivo Correlation in Pharmaceuticals
Explore the concept of in-vitro and in-vivo correlation (IVIVC) in the pharmaceutical industry, as defined by the FDA and USP. Learn how these predictive mathematical models link in-vitro properties of dosage forms to in-vivo responses for drug dissolution and absorption. Discover the roles of IVIVC in quality control, formulation selection, and more.
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INVITRO -INVIVO CORELATIONSHIP Dr. Kalpana School of Pharmaceutical Sciences, CSJMU Kanpur.
INVITRO -INVIVO CORELATIONSHIP An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. 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 invivo 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 roles of IVIVC are: To use dissolution test as a surrogate for human studies. To supports and/or validate the use of dissolution methods and specifications. To assist in quality control during manufacturing and selecting appropriate formulation
https://www.slideshare.net/ANUSHANADIKATLA/in-vitro-in-vivo-correlation-https://www.slideshare.net/ANUSHANADIKATLA/in-vitro-in-vivo-correlation- 122984972 BioPharmaceutics and Pharmacokinetics (Brahamankar and Jaiswal)
