FDA regulatory considerations for oncology drug development.

IF 2.9 4区医学 Q2 PHARMACOLOGY & PHARMACY

Pharmacology Research & Perspectives Pub Date : 2024-08-01 DOI:10.1002/prp2.1254

Hanlim Moon, Dae Young Zang, Min-Hee Ryu, YeonSook Seo, Bitna Oh, Sunjin Hwang, Lee Farrand

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美国食品及药物管理局对肿瘤药物开发的监管考虑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacology Research & Perspectives Pharmacology, Toxicology and Pharmaceutics-General Pharmacology, Toxicology and Pharmaceutics

CiteScore

5.30

自引率

3.80%

发文量

120

审稿时长

20 weeks

期刊介绍： PR&P is jointly published by the American Society for Pharmacology and Experimental Therapeutics (ASPET), the British Pharmacological Society (BPS), and Wiley. PR&P is a bi-monthly open access journal that publishes a range of article types, including: target validation (preclinical papers that show a hypothesis is incorrect or papers on drugs that have failed in early clinical development); drug discovery reviews (strategy, hypotheses, and data resulting in a successful therapeutic drug); frontiers in translational medicine (drug and target validation for an unmet therapeutic need); pharmacological hypotheses (reviews that are oriented to inform a novel hypothesis); and replication studies (work that refutes key findings [failed replication] and work that validates key findings). PR&P publishes papers submitted directly to the journal and those referred from the journals of ASPET and the BPS