FDA introductory comments: clinical studies design and evaluation issues.

作者信息

Woodcock Janet

机构信息

Food and Drug Administration, Rockville, MD 20857, USA.

出版信息

Clin Trials. 2005;2(4):273-5. doi: 10.1191/1740774505cn096oa.

DOI:10.1191/1740774505cn096oa

PMID:16281424

Abstract

摘要

相似文献

FDA introductory comments: clinical studies design and evaluation issues.

Clin Trials. 2005;2(4):273-5. doi: 10.1191/1740774505cn096oa.

The FDA and IBS drug development.

Am J Gastroenterol. 2009 Dec;104(12):3106; author reply 3106. doi: 10.1038/ajg.2009.445.

Green light from the FDA for new drug development in irritable bowel syndrome and functional dyspepsia.

Am J Gastroenterol. 2009 Jun;104(6):1339-41. doi: 10.1038/ajg.2009.295.

Evaluation of the Inclusion of Studies Identified by the FDA as Having Falsified Data in the Results of Meta-analyses: The Example of the Apixaban Trials.

JAMA Intern Med. 2019 Apr 1;179(4):582-584. doi: 10.1001/jamainternmed.2018.7661.

Dermatology clinical trials and drug development.

Dermatol Nurs. 2003 Oct;15(5):428-34.

FDA seeks swifter approval of drugs for some life-threatening or debilitating diseases.

JAMA. 1988 Nov 25;260(20):2976.

A proposal for radical changes in the drug-approval process.

N Engl J Med. 2006 Aug 10;355(6):618-23. doi: 10.1056/NEJMsb055203.

Comments on the FDA draft guidance on biosimilar products.

Stat Med. 2013 Feb 10;32(3):364-9. doi: 10.1002/sim.5572. Epub 2012 Aug 18.

FDA signals it's open to drug trials that shift midcourse.

Wall St J (East Ed). 2006 Jul 10:B1, B8.

Drug development process for a product with a primary pediatric indication.

J Clin Psychiatry. 2002;63 Suppl 12:44-9.

引用本文的文献

Pilot testing the effectiveness of whether a survey-driven tablet-based intervention increased willingness of Black women to attend to an initial PrEP clinic visit: The protocol for the pilot randomized controlled trial design and methods.

Contemp Clin Trials Commun. 2022 Aug 27;29:100985. doi: 10.1016/j.conctc.2022.100985. eCollection 2022 Oct.

Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial.

Nicotine Tob Res. 2021 Aug 29;23(10):1682-1690. doi: 10.1093/ntr/ntab066.

Differences between Frequentist and Bayesian inference in routine surveillance for influenza vaccine effectiveness: a test-negative case-control study.

BMC Public Health. 2021 Mar 16;21(1):516. doi: 10.1186/s12889-021-10543-z.

Bayesian statistics and clinical trial designs for human cells and tissue products for regulatory approval.

Regen Ther. 2016 Oct 10;5:86-95. doi: 10.1016/j.reth.2016.09.001. eCollection 2016 Dec.

Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial.

Medicine (Baltimore). 2018 Jan;97(2):e9567. doi: 10.1097/MD.0000000000009567.

Changing the Paradigm for the Treatment and Development of New Therapies for FSGS.

Front Pediatr. 2016 Mar 23;4:25. doi: 10.3389/fped.2016.00025. eCollection 2016.

Adaptive clinical trial designs in oncology.

Chin Clin Oncol. 2014 Dec;3(4). doi: 10.3978/j.issn.2304-3865.2014.06.04.

Adaptive design clinical trials: Methodology, challenges and prospect.

Indian J Pharmacol. 2010 Aug;42(4):201-7. doi: 10.4103/0253-7613.68417.

Adaptive design methods in clinical trials - a review.

Orphanet J Rare Dis. 2008 May 2;3:11. doi: 10.1186/1750-1172-3-11.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验

Suppr
超能文献

FDA introductory comments: clinical studies design and evaluation issues.

作者信息

机构信息

出版信息

相似文献

引用本文的文献

文献AI研究员

用中文搜PubMed

文档翻译

Suppr 超能文献

相似文献

引用本文的文献

Suppr超能文献

FDA introductory comments: clinical studies design and evaluation issues.

作者信息

机构信息

出版信息

相似文献

引用本文的文献

文献AI研究员

用中文搜PubMed

文档翻译

Suppr 超能文献

相似文献

引用本文的文献

Suppr
超能文献