Drugs proposed decision tree

A Proposed Decision Tree to Select Interfaces for Drug Discovery... 

Decision trees for optimal drug design strategies have been proposed by Topliss [64] and by Purcell et al. [65]. 

The process of qualifying an individual impurity or a given impurity profile at a specified level(s) is summarized in Table 1.1. Safety studies can be conducted on the drug containing the impurity or on the isolated impurity. Several decision trees have been proposed describing threshold levels... 

This draft, issued in November 1993, included for the first time a decision tree detailing how a product should be treated. This scheme proposed that if the directly exposed product was stable, the testing should end and no labeling statement would be required. This discounted any possible contribution of packaging leachables to the photoinstability of drug substances and products. 

In addition, the ICH proposed guidelines for the development of specifications related to drug substance and drug product performance (ICH Q6A and decision trees).To increase the understanding of product performance and ensure that the product will function as expected, the tests discussed in this chapter include noninvasive and nondestructive in situ tests which ensure that the API incorporated into the dosage unit is in a specified, physical form. 

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