Review of Transporter-Related Postmarketing Requirement or Postmarketing Commitment Studies.

Abstract

The objectives of this report are to summarize the content and status of transporter-related postmarketing requirement (PMR)/postmarketing commitment (PMC) studies in new drug applications (NDAs) approved by the U.S. Food and Drug Administration (FDA) and to discuss the reasons for requesting such studies and the impact of PMR/PMC study results on labeling… (More)
DOI: 10.1002/jcph.770

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