Reducing time to market with a science-based product management strategy

Pharmaceutical Technology

Volumn 29, Issue 8 SUPPL., 2005, Pages 46-56

  Byrn, Stephen ^a,b,c   Morris, Kenneth ^a,d   Comella, Shawn ^a  

^a SSCI Incorporated   (United States)

^b Department of Medicinal Chemistry ^*  (United States)

^c PURDUE UNIVERSITY   (United States)

^d PURDUE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PHARMACEUTICAL COMPANIES; SCIENCE-BASED PRODUCT MANAGEMENT;

CHEMICAL INDUSTRY; DRUG PRODUCTS; DRUG PRODUCTS PLANTS;

PRODUCT DEVELOPMENT;

ANALYTIC METHOD; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; MANAGEMENT; MARKET; QUALITY CONTROL; REVIEW; TECHNOLOGY;

EID: 24644478114     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (7)

1. Tufts Center for the Study of Drug Development, Approved NCE Database, http://csdd.tufts.edu.
2. The Pink Sheet (F-D-C Reports, Chevy Chase, MD, Nov. 29, 2004), p. 29.
3. Yu et al., "New Polymorphs of ROY and a New Record for Coexisting Polymorphs of Solved Structures," J. Amer. Chem. Soc. (in press).
4. White and Kearney, Pharmaceutical R&D Statistical Sourcebook 2005-2006 (PAREXEL International Corp., Waltham, MA), p. 27.
5. G. Pisano, The Development Factory (Harvard Business School Press, Cambridge, MA, 1994).
6. International Conference on Harmonization (ICH), Q8 Draft Guidance: Pharmaceutical Development (ICH, Geneva, Switzerland), www.fda.gov/cder/.
7. ICH, M4 Guidance: The Common Technical Document (ICH, Geneva, Switzerland), www.fda.gov/cder/.