Pharmaceutical development phases: A duration analysis

Journal of Pharmaceutical Finance, Economics and Policy

Volumn 14, Issue 4, 2006, Pages 19-41

  Abrantes Metz, Rosa M ^a   Adams, Christopher P ^b   Metz, Albert D ^c  

^a NERA ECONOMIC CONSULTING   (United States)

^b FEDERAL TRADE COMMISSION   (United States)

^c MOODY'S INVESTORS SERVICE   (United States)

Author keywords

Clinical trials; Drug development; Marketing duration; Regulatory renew

Indexed keywords

ARTICLE; CANCER THERAPY; CENSORSHIP; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEALTH ECONOMICS; MATHEMATICAL COMPUTING; PATENT; PRIORITY JOURNAL; PROBABILITY; STATISTICAL ANALYSIS; STATISTICAL MODEL; TREATMENT FAILURE; TREATMENT INDICATION;

EID: 33746708725     PISSN: 15385698     EISSN: 15385396     Source Type: Journal    
DOI: 10.1300/J371v14n04_03     Document Type: Article

References (23)

1. Abbring, J., van den Berg, G. (2003). The Identifiability of the Mixed Proportional Hazards Competing Risks Model. Forthcoming in J. Royal Statistical Society, Series B. , January 30, 2003.
2. Adams, C. and Brantner, V. (2003). New Drug Development: Estimating entry from human clinical trials. Federal Trade Commission Working Paper Series #262. July 2003.
3. Adams, C. and Brantner, V. (2004). Estimating the Cost of New Drug Development: Is it really $802m? Federal Trade Commission. December 2004.
4. Berndt, E., Gottschalk, A., Philipson, T., and Strobeck, M. (2005). Industry Funding of the FDA: Effects of PDUFA on Approval Times and Withdrawal Rates. Nature Review: Drug Discovery, 4: 545-554.
5. Bonnal, L., Fougere, D., and Serandon, A. (1997). Evaluating the impact of French employment policies on individual labour market histories. Review of Economic Studies, 64: 686-713.
6. Danzon, P., Epstein, A. and Nicholson, S. (2003). Mergers and Acquisitions in the Pharmaceutical and Biotech Industries. September 2003. The Wharton School, University of Pennsylvania.
7. DiMasi, J., Hansen, R., and Grabowski, H. (1991). The cost of innovation in the pharmaceutical industry. Journal of Health Economics, 10: 107-142.
8. DiMasi, J. and Grabowski, H. (1995a). R&D costs, innovative output and firm size in the pharmaceutical industry. International Journal of the Economics of Business, 2: 201-221.
9. DiMasi, J., Hansen, R., Grabowski, H., and Lasagna, L. (1995b). Research and Development Costs for New Drugs by Therapeutic Category. PharmacoEconomics, 7: 152-169.
10. DiMasi, J. (2001). Risks in New Drug Development: Approval Success Rates for Investigational Drugs. Clinical Pharmacology & Therapeutics, May 2001, 297-307.
11. DiMasi, J., Hansen, R., and Grabowski, H. (2003). The price of innovation: new estimates of drug development costs. Journal of Health Economics, 22: 151-185.
12. Dranove, D. and Meltzer, D. (1994). Do important drugs reach the market sooner? RAND Journal of Economics, 25(3): 402-422.
13. Duggan, M. and Evans, W. (2005). Estimating the Impact of Medical Innovation: The case of HIV antitretroviral treatments. University of Maryland. January 2005.
14. FDA/Center for Evaluation and Research (2001). FDA's Drug Review and Approval Times. CDER. July 2001.
15. FDA and the Drug Development Process (2002). How the Agency Ensures that Drugs are Safe and Effective. Department of Health and Human Resources, Publication No. FS 02-5, February 2002.
16. FDA (2003). New Drug Approval Reports. http://www.fda.gov/cder/rdmt/ default.htm.
17. Lancaster, T. (1997). The Econometric Analysis of Transition Data. Cambridge University Press.
18. Meadows, M. (2002). The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective. FDA.
19. Metz, A. (2003). A Technical Note on Multiple State Duration Models: Extending the General Multiple-Destination and Competing-Risk Models to Discrete Time. Congressional Budget Office.
20. Meyer, B. (1990). Unemployment Insurance and Unemployment Spells. Econometrica, 58: 757-782.
21. Peltzman, S. (1973). An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. Journal of Political Economy, 81: 1049-1091.
22. Pharmaprojects User's Handbook 2002. Pharmaprojects, Volume 23.
23. van den Berg, G. (2000). Duration Models: Specification, Identification, and Multiple Durations. Handbook of Econometrics, Volume 5, Edited by James J. Heckman and Edward Leamer.