Innovative approaches in drug development.

This is the white paper on Innovative Approaches in Drug Development developed by the Biotechnology Industry Organization's (BIO) Clinical Trial Designs Workgroup. As recognized by the Food and Drug Administration's Critical Path Opportunities Report, the need to develop and apply innovative approaches to create new trial designs and clinical development programs is rapidly on the rise. Such novel approaches hold tremendous potential in the ability to refine mechanisms lying at the fundamental core of product safety and efficacy.

Scientific considerations of pharmaceutical solid polymorphism in abbreviated new drug applications.

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.