Predictive Conversion of In Vitro Drug Dissolution Data into In Vivo Drug Response versus Time Profiles Exemplified for Plasma Levels of Warfarin

A mathematical approach to computing the in vivo drug response profiles (such as plasma level, pharmacological response, and urinary recovery versus time curves) corresponding to observed in vitro dissolution of drug dosage form versus time profiles is described. The method is exemplified for warfar...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1977-03, Vol.66 (3), p.297-304
Main Authors: Smolen, Victor F., Erb, Randall J.
Format: Article
Language:English
Subjects:
Computers, Analog
Dissolution data
Dissolution data, in vitro—predictive conversion into in vivo drug response-time profiles, plasma warfarin levels
Drug response profiles
Drug response profiles, in vivo—plasma warfarin levels, predicted from in vitro dissolution data
Fourier Analysis
Humans
in vitro-predictive conversion into in vivo drug response-time profiles
in vivo-plasma warfarin levels
Mathematics
Models, Biological
plasma warfarin levels
predicted from in vitro dissolution data
Solubility
Tablets
Time Factors
Warfarin - administration & dosage
Warfarin - blood
Warfarin - pharmacology
Warfarin-plasma levels predicted from in vitro dissolution data
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Summary:A mathematical approach to computing the in vivo drug response profiles (such as plasma level, pharmacological response, and urinary recovery versus time curves) corresponding to observed in vitro dissolution of drug dosage form versus time profiles is described. The method is exemplified for warfarin tablets, for which observed in vivo plasma level profiles are compared to corresponding predicted profiles computed from in vitro dissolution data. The potential of the method is demonstrated; approaches to its improvement, as well as its limitations, are discussed.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.2600660302