Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report-Reference-Cited by-同舟云学术

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report

Published:2010-02 Issue:1 Volume:23 Page:1-29
ISSN:1941-2711
Container-title:Journal of Aerosol Medicine and Pulmonary Drug Delivery
language:en
Short-container-title:Journal of Aerosol Medicine and Pulmonary Drug Delivery

Author:

Adams Wallace P.¹,Ahrens Richard C.²,Chen Mei-Ling³,Christopher David⁴,Chowdhury Badrul A.³,Conner Dale P.¹,Dalby Richard⁵,Fitzgerald Kevin⁶,Hendeles Leslie⁷,Hickey Anthony J.⁸,Hochhaus Günther⁹,Laube Beth L.¹⁰,Lucas Paul¹¹,Lee Sau L.¹,Lyapustina Svetlana¹²,Li Bing¹,O'Connor Dennis¹³,Parikh Neil¹⁴,Parkins David A.¹⁵,Peri Prasad³,Pitcairn Gary R.¹⁶,Riebe Michael¹⁷,Roy Partha³,Shah Tushar¹⁸,Singh Gur Jai Pal¹⁹,Sharp Sandra Suarez³,Suman Julie D.²⁰,Weda Marjolein²¹,Woodcock Janet³,Yu Lawrence¹

Affiliation:

1. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, Rockville, Maryland.

2. University of Iowa Hospitals and Clinics, Department of Pediatrics, Iowa City, Iowa.

3. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.

4. Schering Plough Research Institute, Kenilworth, New Jersey.

5. University of Maryland, Baltimore Maryland.

6. GlaxoSmithKline, Research Triangle Park, North Carolina.

7. University of Florida, Gainesville, Florida.

8. School of Pharmacy, UNC at Chapel Hill, Chapel Hill, North Carolina.

9. Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, Florida.

10. Johns Hopkins University School of Medicine, Baltimore, Maryland.

11. Pfizer Global Research and Development, Sandwich, Kent, CT13 9NJ, United Kingdom.

12. IPAC-RS, Washington, DC.

13. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

14. Axar Pharma, Irvine, California.

15. GlaxoSmithKline R&D, Ware, SG12 0DP, United Kingdom.

16. Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.

17. Merck & Co Inc., West Point, Pennsylvania.

18. Teva Pharmaceuticals, Horsham, Pennsylvania.

19. Watson, Corona, California.

20. Next Breath, LLC, Baltimore, Maryland.

21. National Institute for Public Health and the Environment (RIVM) Centre for Quality of Chemical-Pharmaceutical Products, Bilthoven, The Netherlands.

Publisher

Mary Ann Liebert Inc

Subject

Pharmacology (medical),Pharmaceutical Science,Pulmonary and Respiratory Medicine

Link

http://www.liebertpub.com/doi/pdf/10.1089/jamp.2009.0803

Reference64 articles.

1. AAPS PharmSciTech volume 8, issue 4 — Editorial

2. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: Background for a statistical method

3. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 2—Evaluation of a method for determining equivalence

4. Product quality research institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: Final report on a statistical procedure for determining equivalence

5. A methacholine challenge dose-response study for development of a pharmacodynamic bioequivalence methodology for albuterol metered-dose inhalers

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