Evaluation of Therapeutics for Advanced-Stage Heart Failure and Other Severely-Debilitating or Life-Threatening Diseases-Reference-Cited by-同舟云学术

Evaluation of Therapeutics for Advanced-Stage Heart Failure and Other Severely-Debilitating or Life-Threatening Diseases

Published:2017-06-21 Issue:2 Volume:102 Page:219-227
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Prescott JS¹,Andrews PA²,Baker RW³,Bogdanffy MS⁴,Fields FO⁵,Keller DA⁶,Lapadula DM⁷,Mahoney NM⁸,Paul DE⁹,Platz SJ¹⁰,Reese DM¹¹,Stoch SA¹²,DeGeorge JJ¹

Affiliation:

1. Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc.; West Point Pennsylvania USA

2. Global Regulatory Affairs, Eisai, Inc; Woodcliff Lake New Jersey USA

3. Global Patient Safety, Eli Lilly & Co; Indianapolis Indiana USA

4. Boehringer Ingelheim Pharmaceuticals, Inc; Ridgefield Connecticut USA

5. Worldwide Safety and Regulatory, Pfizer Research and Development; Collegeville Pennsylvania USA

6. Preclinical Safety, Sanofi US; Bridgewater New Jersey USA

7. Preclinical Safety, Novartis Institutes for Biomedical Research; East Hanover New Jersey USA

8. Regulatory Affairs, Merck & Co., Inc; Rockville Maryland USA

9. US Regulatory Policy & Strategy, Eli Lilly & Co; Indianapolis Indiana USA

10. Drug Safety & Metabolism, Innovative Medicines and Early Development; AstraZeneca Cambridge UK

11. Translational Sciences, Amgen; Thousand Oaks California USA

12. Translational Pharmacology, Merck & Co., Inc; Kenilworth New Jersey USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.730/fullpdf

Reference27 articles.

1. US Food and Drug Administration https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:5.0.1.1.3.5

2. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Step4/S9_Step4_Guideline.pdf

3. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Draft guidance for industry. Rare diseases: common issues in drug development http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458485.pdf

4. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Guidance for industry Expedited programs for serious conditions - drug and biologics (May 2014) http://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf

5. European Medicines Agency PRIME: priority medicines http://www.ema.europa.eu/ema/index.jsp%3Fcurl%3Dpages/regulation/general/general_content_000660.jsp%26mid%3DWC0b01ac058096f643

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