Analytical Requirements for Drug Eluting Stents

Author:

Alquier Lori1,Ranade Shrirang V.2

Affiliation:

1. The Janssen Pharmaceutical Companies of Johnson & Johnson; Raritan; New Jersey USA

2. Genentech Inc.; a member of the Roche Group; South San Francisco California USA

Publisher

John Wiley & Sons, Inc.

Reference31 articles.

1. Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach;Bansal;AAPS PharmSciTech,2004

2. Risk-based validation of commercial off-the-shelf computer systems;Huber;J. Validat. Technol,2005

3. Molecular imaging of drug-eluting coronary stents: Method development, optimization and selected applications;Huang;J. Mass Spectrom,2012

4. FDA Guidance for industry - coronary drug-eluting stents http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM228704.pdf 2008

5. Stability testing of new drug substances and products 2003

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