Clinical development of anticancer drugs can be enhanced using efficacy data of small population clinical trials-Reference-Cited by-同舟云学术

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Clinical development of anticancer drugs can be enhanced using efficacy data of small population clinical trials

Published:2022-05-07 Issue:9 Volume:47 Page:1388-1394
ISSN:0269-4727
Container-title:Journal of Clinical Pharmacy and Therapeutics
language:en
Short-container-title:Clinical Pharmacy Therapeu

Author:

Sawachi Keiichi¹²^ORCID,Matsumaru Naoki¹^ORCID,Tsukamoto Katsura¹^ORCID

Affiliation:

1. Global Regulatory Science Gifu Pharmaceutical University Gifu Japan

2. Development Astellas Pharma Inc Tokyo Japan

Publisher

Hindawi Limited

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jcpt.13676

Reference21 articles.

1. Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan

2. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate

3. Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

4. Food and Drug Administration.CDER drug and biologic accelerated approvals based on a surrogate endpoint. Accessed December 31 2020.https://www.fda.gov/media/88907/download.

5. “Dangling” Accelerated Approvals in Oncology

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