Polymorphism decision tree

Decision Tree Investigating the Need to Set Acceptance Criteria for Polymorphism in Drug Substances and Drug Products, International Conference on Harmonization (ICH) Guideline Specification Q6A, 1999. 

The sequential decision tree approach considers whether polymorphism in a drug substance can affect performance of the drug product and leads to a final decision point for determining whether polymorph specifications need to be set for a drug product. 

Scheme 6 Decision tree for the disposition of polymorphism. Source Courtesy of Pharmquest Corporation, Mountain View, California, U.S.A.

The first step in the decision tree for polymorphism analysis (fig. 4.4) is a simple question is the polymorphism located in an exon Answering this accurately may... 

Owing to the inherent physical and chemical instabilities of thermodynamically less stable forms, the International Committee on Harmonisation has issued a guidance [14] containing a decision tree for investigating the need to set acceptance criteria for polymorphism in dmg substances and drug products (see Figs... 

Fig. 7.3 ICH Q6A decision tree that investigates the need to set acceptance criteria for polymorphism in drug substances [14].

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