Investigating relationships betweenin vivo andin vitro pharmacological variables for the purpose of prediction
prediction ofin vivo response
in vivo-in vitro correlation
Springer Online Journal Archives 1860-2000
Chemistry and Pharmacology
Abstract Consistency of effect in vivois an important characteristic of a drug product, and great variation from lot to lot or between manufacturers is not desirable. The variation usually arises when some lots fail to meet minimum standards. It may then be necessary to develop a procedure for detecting and screening out these defective lots. A new, heuristic approach is presented for evaluating procedures in which screening is to be based on in vitromeasurements rather than more costly in vivomeasures. A quantification of risks is defined from which a minimum (in a certain sense) risk procedure may be selected from a set of candidate procedures. This approach is shown to be more appropriate than those based on correlational techniques.
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