J. Mark Wiggins

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

This position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.