Moving from Vial to Prefilled Syringe - Pharmaceutical Technology

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Moving from Vial to Prefilled Syringe
A Project Manager's Perspective.


Pharmaceutical Technology


References

1. J.A. DiMasi, R.W. Hansen, and H.G. Grabowski, "The Price of Innovation: New Estimates of Drug Development Costs," Jrnl. of Health Econ. 22 (2), p. 151 (2003).

2. B. Harrison and M. Rios, "Big Shot: Developments in Prefilled Syringes," Pharm. Technol. 31 (3) 50–60 (2007).

3. Frost and Sullivan, US Drug Delivery: Usage Patterns, Preferences and Opportunities in the USPhysicians' Perspective, Vol. 2, 2008.

4. Frost and Sullivan, US Drug Delivery: Usage Patterns, Preferences and Opportunities in the US—The Patient's Perspective, Vol. 1, 2008.

5. M. Borlet, "Financial Model for Converting from a Vial to a Pre-filled Syringe," in The Universe of Pre-Filled Syringes and Injection Devices, presented at PDA, San Diego, CA, 2008.

6. T. Polen, "Enhanced Packaging and Reformulations Give New Life to Biologics," BioPharm Int. 19 (10) 60–66 (2006).

7. FDA, 21 USC 356a, Sec. 506 A, Manufacturing Changes (Bethesda, MD, 2009).

8. R. Gibson, "Moving to a Pre-filled Syringe: Stability Considerations—A Regulatory Perspective" in The Universe of Pre-Filled Syringes and Injection Devices, presented at PDA, San Diego, CA, 2008.

9. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 211.166.

10. K. Davis, "Biopharmaceutical Manufacturing: The Challenge of Global Regulatory Compliance," Pharm. Technol. 32 (2) 60–68 (2008).

11. Drugs@FDA, http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.DrugDetails, accessed July 7, 2009.

12. FDA, Approval Letter: Fluzone, Sept. 4, 2002 (updated May 15, 2009), http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123732.htm, accessed July 8, 2009.

13. FDA, Approval Letter—Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, June 8, 2006 (updated May 1, 2009), http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111283.htm, accessed July 8, 2009.

14. FDA, Approval Letter, Feb. 17, 2000 (updated Mar. 4, 2002), http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm137057.htm, accessed July 8, 2009.

15. FDA Approved Products, Pneumococcal 7-valent Conjugate Vaccine [package insert], Oct. 2008, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM137038.pdf, accessed July 8, 2009.


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