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Scientific considerations of pharmaceutical solid polymorphism in abbreviated new drug applications
Lawrence X Yu1, M Scott Furness, Andre Raw
1Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA. yul@cder.fda.gov
Purpose:
This commentary is intended to provide a scientific perspective on pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs).
Methods:
This report proposes recommendations for monitoring and controlling drug substance polymorphs and describes scientific considerations of pharmaceutical solid polymorphism in the determination of drug substance sameness.
Results:
It presents three decision trees for solid oral dosage forms or liquids containing undissolved drug substances to provide a process for evaluating when and how polymorphs of drug substances are monitored and controlled in ANDA submissions.
Conclusions:
It is scientifically concluded that differences in polymorphic composition of drug substances in generic drug products and reference-listed drugs are not directly relevant in the determination of drug substance sameness in ANDAs.