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Engaging patients in medicines regulation: a tale of two agencies.

作者信息

Mavris Maria, Furia Helms Andrea, Bere Nathalie

出版信息

Nat Rev Drug Discov. 2019 Nov;18(12):885-886. doi: 10.1038/d41573-019-00164-y.


DOI:10.1038/d41573-019-00164-y
PMID:31780842
Abstract
摘要

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引用本文的文献

[1]
Characterising meaningful patient and public involvement in the pharmaceutical industry research setting: a retrospective quality assessment.

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[2]
Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis.

BMJ Med. 2022-11-3

[3]
Innovative Designs and Logistical Considerations for Expedited Clinical Development of Combination Disease-Modifying Treatments for Type 1 Diabetes.

Diabetes Care. 2022-10-1

[4]
Practices of patient engagement in drug development: a systematic scoping review.

Res Involv Engagem. 2022-6-29

[5]
Patient-Centered Core Impact Sets: What They are and Why We Need Them.

Patient. 2022-11

[6]
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.

Ther Innov Regul Sci. 2022-11

[7]
Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance.

Trials. 2022-1-15

[8]
Co-creation of practical "how-to guides" for patient engagement in key phases of medicines development-from theory to implementation.

Res Involv Engagem. 2021-8-23

[9]
Translational precision medicine: an industry perspective.

J Transl Med. 2021-6-5

[10]
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action.

Ther Innov Regul Sci. 2021-9

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