Risk management in the pharmaceutical product development process

Journal of Pharmaceutical Innovation

Volumn 3, Issue 4, 2008, Pages 227-248

  Hulbert, Matthew H ^a   Feely, Liam C ^b   Inman, Eugene L ^c   Johnson, Alton D ^d   Kearney, Albert S ^e   Michaels, James ^f   Mitchell, Michael ^f   Zour, Elena ^g  

^a CEPHALON INC   (United States)

^b ABBOTT LABORATORIES   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d PFIZER INC   (United States)

^e GLAXOSMITHKLINE   (United States)

^f MERCK RESEARCH LABORATORIES   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

Author keywords

Case studies; Quality by design; Risk acceptance; Risk assessment

Indexed keywords

DRUG;

ARTICLE; CARCINOGENICITY; DRUG APPROVAL; DRUG DESIGN; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SCREENING; DRUG STORAGE; GENOTOXICITY; HUMAN; MUTAGENICITY; PATIENT SAFETY; PRIORITY JOURNAL; PROCESS TECHNOLOGY; QUALITY CONTROL; RISK MANAGEMENT;

EID: 58149083703     PISSN: 18725120     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12247-008-9049-8     Document Type: Article

References (7)

1. ICH Harmonized Tripartite Guideline, ICH Q8: Pharmaceutical development (Nov 10, 2005).
2. FDA Draft Guidance, Q8(R1): Pharmaceutical development revision 1 (Jan 14, 2008).
3. ICH Harmonized Tripartite Guideline, ICH Q9: Quality risk management (Nov 9, 2005).
4. ICH Draft Consensus Guideline, ICH Q10: Pharmaceutical quality system (May 9, 2007).
5. The Food and Drug Administration's Strategic Action Plan Protecting and Advancing America's Health: Responding to new challenges and opportunities (Aug 2003).
6. Müller L, Mauthe RJ, Riley CM, Andino MM, De Antonis D, Beels C, et al. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess the potential for genotoxicity. Regul Toxicol Pharm 2006;44:198-211.
7. MacGregor JF, Yu H, García-Muñoz S, Flores-Cerrillo J. Data-based latent variable methods for process analysis, monitoring and control. Comput Chem Eng 2005;29:1217-23.