The Role of Drug Exposure in Clinical Development: To What Extent Is Pharmacokinetic Assessment Needed in a Drug Development Programme?-Reference-Cited by-同舟云学术

The Role of Drug Exposure in Clinical Development: To What Extent Is Pharmacokinetic Assessment Needed in a Drug Development Programme?

Published:2015-05-27 Issue:10 Volume:54 Page:985-987
ISSN:0312-5963
Container-title:Clinical Pharmacokinetics
language:en
Short-container-title:Clin Pharmacokinet

Author:

Goyal Navin

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s40262-015-0287-x.pdf

Reference5 articles.

1. Code of Federal Regulations (CFR) Title 21, Office of the Federal Registrar, National Archives and Records Administration, USA; 2015.

2. Gibbons JA, et al. Clinical pharmacokinetic studies of enzalutamide. Clin Pharmacokinet. 2015. doi: 10.1007/s40262-015-0271-5 .

3. Gibbons, JA, et al. Pharmacokinetic drug interaction studies with enzalutamide. Clin Pharmacokinet. 2015. doi: 10.1007/s40262-015-0283-1 .

4. Scher HI, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1–2 study. Lancet. 2010;375(9724):1437–46.

5. US Department of Health and Human Services. Guidance for industry, drug interaction studies—2012. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm292362.pdf . Accessed 1 May 2015.

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