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In vitro/in vivo correlations: scientific implications and standardisation
1Biopharmaceutics Research Center, CIBA-GEIGY Laboratories, Rueil-Malmaison, France.
European Journal of Drug Metabolism and Pharmacokinetics
|January 1, 1993
Summary
Establishing Level A in vitro/in vivo correlations is crucial for modified release drug development. Early, a priori correlations offer superior predictive power over a posteriori correlations, requiring strict development methodologies.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Biopharmaceutics
Background:
- In vitro/in vivo correlations (IVIVCs) are essential for drug product development.
- The United States Pharmacopeia (USP) and FDA working groups have defined correlation parameters.
- Level A correlation offers the most significant insights into drug product performance.
Purpose of the Study:
- To mathematically and biopharmaceutically analyze Level A in vitro/in vivo correlation.
- To discuss prerequisites for establishing robust correlations.
- To define the role of IVIVCs in modified-release dosage form development.
Main Methods:
- Exploration of mathematical and biopharmaceutical aspects of Level A correlation.
- Discussion of methodological requirements for establishing IVIVCs.
- Analysis of the timing and validation of IVIVCs during product development.
Main Results:
- Level A correlation is the most informative type of IVIVC.
- Strict development methodologies are necessary for successful IVIVC establishment.
- A priori IVIVCs are more predictive than a posteriori IVIVCs.
Conclusions:
- In vitro/in vivo correlations are vital for modified-release drug development.
- Early establishment (a priori) of IVIVCs is recommended for optimal predictive power.
- A posteriori IVIVCs require additional validation due to limited predictive capacity.