Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression-Reference-Cited by-同舟云学术

Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression

Published:2020-10-13 Issue:2 Volume:109 Page:536-546
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Katz Eva G.¹,Hough David²³,Doherty Teodora²,Lane Rosanne²,Singh Jaskaran⁴⁵,Levitan Bennett²

Affiliation:

1. Janssen Research & Development, LLC Raritan New Jersey USA

2. Janssen Research & Development, LLC Titusville New Jersey USA

3. Former employee of Janssen Research and Development, LLC Titusville New Jersey USA

4. Janssen Research & Development, LLC San Diego California USA

5. Neurocrine Biosciences San Diego California USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2024

Reference36 articles.

1. US Food and Drug Administration.Structured approach to benefit‐risk assessment in drug regulatory decision‐making (2019). Accessed November 15 2019.

2. State of the art in benefit–risk analysis: Medicines

3. Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions

4. ICH harmonised guideline: revision of M4E guideline on enhancing the format and structure of benefit‐risk information in ICH efficacy ‐ M4E(R2) (2016). Accessed March 12 2020.

5. A Concise Display of Multiple End Points for Benefit–Risk Assessment

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