What is in vitro in vivo correlation?
An in vitro – in vivo correlation (IVIVC) is defined by the U.S Food and Drug Administration (FDA) as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.
What is the significance of IVIVC?
IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development as the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability and to support biowaivers.
What is IVIVC Slideshare?
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”. Read more. Mohammad Imran. Research Scholar Jamia Hamdard.
What is in vivo dissolution profile?
In Vivo Dissolution Assessment Profiles obtained after oral administration of a solution are a function of the same functions with the exception of in vivo dissolution as the drug is already dissolved.
What is in vitro in vivo correlation Slideshare?
Definition “In vitro-in vivo correlation is defined as the predictive mathematical model that describes the relationship between an in-vitro property (such as the rate of dissolution) of a dosage form and an in-vivo response (such as the plasma drug concentration).” 5.
How does IVIVC help in product development?
IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies required during formulation development. It supports and/or validates the use of dissolution methods and specification settings. It can also assist in quality control for certain scale-up and post-approval changes (SUPAC).
How many levels are in IVIVC?
There are three primary IVIVC categories, known as Levels A, B, and C. There is also a subcategory known as multiple Level C correlation. Level A is the most common type of IVIVC and historically used primarily for NDAs and investigational new drug (IND) applications.
What is 90 confidence interval in bioequivalence?
A test product is said to be average bioequivalent to a reference (innovative) product if the 90% confidence interval of the ratio of means (after log-transformation) is totally within (80%, 125%).
How do you measure bioavailability?
- Equation 1: Vd = total amount of drug in the body ÷ plasma drug concentration.
- Equation 2: F = mass of the drug delivered to the plasma ÷ total mass of the drug administered.
- Equation 3: F = AUC for X route of administration ÷ AUC for IV administration.
Which criteria is applicable to the development of IVIVC?
The most commonly seen process for developing a Level A IVIVC is to (1) develop formulations with different release rates, such as slow, medium, fast, or a single release rate if dissolution is condition independent; (2) obtain in vitro dissolution profiles and in vivo plasma concentration profiles for these …
How do you develop IVIVC?
The IVIVC model is developed by using the observed fraction of the drug absorbed and that of the drug dissolved. Based on the IVIVC model, the predicted fraction of the drug absorbed is calculated from the observed fraction of the drug dissolved.
Which class of drug has no IVIVC?
In vitro-in vivo correlation and its application
| Class I | High Solubility High Permeability | Correlation (if dissolution is rate-limiting step) |
|---|---|---|
| Class II | Low Solubility High Permeability | IVIVC expected |
| Class III | High Solubility Low Permeability | Little or no IVIVC |
| Class IV | Low Solubility Low Permeability | Little or no IVIVC |