Validation of in Vitro-in Vivo Correlation Models
A valid model can be defined as one that is a) well-grounded on principles or evidence, b) able to withstand criticism or objection, and c) capable of serving the purpose of the model. In the area of mathematical modelling, there are two criteria in the validation process: internal criteria and external criteria (1). The internal criteria establish the validity of a model within the conditions of the model itself (e.g., the model’s consistency and algorithmic integrity). The external criteria, on the other hand, are based on the model’s purpose, theory, and data, considering those conditions that are not internal properties of the model.
KeywordsPrediction Error External Criterion Internal Criterion Draft Guidance Naive Model
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- 1.“The Validation of Models of Metabolic and Endocrine Systems”, Chapter 9, The Mathematical Modeling of Metabolic and Endocrine Systems: Model Formulation, Identification, and Validation. E.Carson, C. Cobelli, L. Finkelstein, 1983, John Wiley & Sons, Inc., Toronto, CanadaGoogle Scholar
- 2.Guidance for Industry: Extended Release Solid Oral Dosage Forms. Development, Evaluation and Application of In Vitro/In Vivo Correlations. Center for Drug Evaluation and Research (CDER), July 1, 1996, FDA Draft Guidelines or Chapter 25 of this publication.Google Scholar
- 3.Scientific Commentary: Some Suggestions for Measuring Predictive Performance. Sheiner, L.B., Beal, S. Journal of Pharmacokinetics and Biopharmaceutics, Vol. 9, No. 4, 1981.Google Scholar
- 4.Resampling Stats: User’s Guide by Julian Simon, 9/1995, Resampling Stats, Inc., Arlington, Virginia.Google Scholar