References
- Basak , A. K. , Raw , A. S. , Al Hakim , A. H. , Furness , S. , Samaan , N. I. , Gill , D. S. and Yu , L. 2007 . Pharmaceutical impurities: Regulatory perspective for Abbreviated New Drug Applications . Advanced Drug Delivery Reviews , 59 : 64 – 72 . (doi:10.1016/j.addr.2006.10.010)
- Beres , D. L. and Hawkins , D. M. 2001 . Plackett-Burman technique for sensitivity analysis of many-parametered models . Ecological Modelling , 141 : 171 – 183 . (doi:10.1016/S0304-3800(01)00271-X)
- BMI . 2008 . Taiwan Pharmaceuticals and Healthcare Report Q2 2008 Business Monitor International
- Cassanelli , G. , Mura , G. , Fantini , F. , Vanzi , M. and Plano , B. 2006 . Failure analysis-assisted FMEA . Microelectronics and Reliability , 46 : 1795 – 1799 . (doi:10.1016/j.microrel.2006.07.072)
- Chauhan , K. , Trivedi , U. and Patel , K. C. 2007 . Statistical screening of medium components by Plackett-Burman design for lactic acid production by Lactobacillus sp. KCP01 using date juice . Bioresource Technology , 98 : 98 – 103 . (doi:10.1016/j.biortech.2005.11.017)
- Dejaegher , B. , Dumarey , M. , Capron , X. , Bloomfield , M. S. and Vander Heyden , Y. 2007 . Comparison of Plackett-Burman and supersaturated designs in robustness testing . Analytica Chimica Acta , 595 : 59 – 71 . (doi:10.1016/j.aca.2006.11.077)
- ICH . Validation of analytical procedures: Text and methodology . International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use . Retrieved November 26, 2011, from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf
- ICH . Quality risk management vol. quality guide . International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use . Retrieved November 26, 2011, from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
- McDermott , R. , Mikulak , R. and Beauregard , M. 1996 . The basics of FMEA , Portland, OR : Quality Resources .
- Meyer , G. F. 1999 . History and regulatory issues of generic drugs . Transplantation Proceedings , 31 : 10S – 12S . (doi:10.1016/S0041-1345(99)00105-0)
- Minitab . 2000 . Minitab User's Guide Release R13 for Windows , State College, PA : Minitab .
- Montgomery , D. C. 2005 . Design and analysis of experiments , 6 Hoboken, NJ: John Wiley & Sons
- National Formulary . 2008 . Validation of compendial procedure , 31 Twinbrook Parkway, Rockville, MD: United States Pharmacopoeia
- NIST . 2006 . NIST/SEMATECH e-handbook of statistical methods , NIST . Retrieved November 21, 2011, from http://www.itl.nist.gov/div898/handbook/
- OGD . 1998 . Requesting methods validation for abbreviated new drug applications (ANDAs) , Rockville, MD : C. F. D. E. A. Research .
- Plackett , R. L. and Burman , J. P. 1946 . The design of optimum multifactorial experiments . Biometrika , 33 : 305 – 325 . (doi:10.1093/biomet/33.4.305)
- PMI . 2004 . A guide to the project management body of knowledge , 3 Newtown Square, PA: PMI
- Pons , D. 2008 . Project management for new product development . Project Management Journal , 39 : 82 – 97 . (doi:10.1002/pmj.20052)
- Prasnikar , J. and Skerlj , T. 2006 . New product development process and time-to-market in the generic pharmaceutical industry . Industrial Marketing Management , 35 : 690 – 702 . (doi:10.1016/j.indmarman.2005.06.001)
- RPI . 2007 . Ranbaxy - Annual Report 2006 Princeton, NJ: RPI. Retrieved November 26, 2011, from http://www.ranbaxy.com/investorinformation/annual_pr2006.aspx
- Swartz , M. and Krull , I. 2007 . 21 CFR Part 11 and risk assessment: Adapting fundamental methodologies to a current rule . LC-GC North America , 25 : 48 – 55 .
- Vatanara , A. , Rouholamini Najafabadi , A. , Gilani , K. , Asgharian , R. , Darabi , M. and Rafiee-Tehrani , M. 2007 . A Plackett-Burman design for screening of the operation variables in the formation of salbutamol sulphate particles by supercritical antisolvent . The Journal of Supercritical Fluids , 40 : 111 – 116 . (doi:10.1016/j.supflu.2006.03.028)
- Watson , D. G. 2005 . Pharmaceutical analysis: A textbook for pharmacy students and pharmaceutical chemists , 2 , Philadelphia, PA : Elsevier .
- Wong , W. and Chatterjee , B. 2007 . Considerations in effectively applying risk-based validation Retrieved November 21, 2011, from http://www.pharmaceuticalonline.com/article.mvc/Considerations-In-Effectively-Applying-Risk-B-0001
- Woolston, C. (2009). Generic drug savings. Retrieved November 21, 2011, from http://drugtools.caremark.com/topic/genericsaving