Nancy A Dreyer

发表的论文8 篇，按出版时间

1. 1
   Real‐world evidence to support regulatory decision making: New or expanded medical product indicationsPharmacoepidemiology and Drug Safety202133
2. 2
   Methods for external control groups for single arm trials or long‐term uncontrolled extensions to randomized clinical trialsPharmacoepidemiology and Drug Safety202074
3. 3
   Considerations when evaluating real‐world data quality in the context of fitness for purposePharmacoepidemiology and Drug Safety202034
4. 4
   Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control armsPharmacoepidemiology and Drug Safety2020125
5. 5
   Trial designs using real‐world data: The changing landscape of the regulatory approval processPharmacoepidemiology and Drug Safety2019253
6. 6
   Comparison of electronic self‐reported prescription medication use during pregnancy with the national prescription register in DenmarkPharmacoepidemiology and Drug Safety20198
7. 7
   Considerations in characterizing real‐world data relevance and quality for regulatory purposes: A commentaryPharmacoepidemiology and Drug Safety201838
8. 8
   Bridge the gap: The need for harmonized regulatory and ethical standards for postmarketing observational studiesPharmacoepidemiology and Drug Safety201710