Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report

Author:

Evans Carole1,Cipolla David2,Chesworth Tim3,Agurell Eva4,Ahrens Richard5,Conner Dale6,Dissanayake Sanjeeva7,Dolovich Myrna8,Doub William9,Fuglsang Anders10,García Arieta Afredo11,Golden Michael12,Hermann Robert13,Hochhaus Günther14,Holmes Susan15,Lafferty Paul16,Lyapustina Svetlana17,Nair Parameswaran8,O'Connor Dennis18,Parkins David19,Peterson Ilse17,Reisner Colin20,Sandell Dennis21,Singh Gur Jai Pal22,Weda Marjolein23,Watson Patricia19

Affiliation:

1. Catalent Pharma Solutions, Research Triangle Park, North Carolina.

2. Aradigm, Hayward, California.

3. AstraZeneca, Macclesfield, United Kingdom.

4. Swedish Medical Products Agency, Uppsala, Sweden.

5. University of Iowa, Iowa City, Iowa.

6. U.S. FDA, Rockville, Maryland.

7. Mundipharma Research, Cambridge, United Kingdom.

8. McMaster University, Hamilton, Ontario, Canada.

9. U.S. FDA, St. Louis, Missouri.

10. Fuglsang Pharma, Rudolstadt, Germany.

11. Spanish Agency for Medicines and Health Care Products, Madrid, Spain.

12. Pearl Therapeutics, Raleigh, North Carolina.

13. Clinical Research Appliance (cr.appliance), Radolfzell, Germany.

14. Univeristy of Florida, Gainesville, Florida.

15. GlaxoSmithKline R&D, Research Triangle Park, North Carolina.

16. Medical Technology Consulting, Hemel Hempstead, United Kingdom.

17. Drinker Biddle & Reath, Washington, DC.

18. Boehringer Ingelheim, Ridgefield, Connecticut.

19. GlaxoSmithKline R&D, Ware, United Kingdom.

20. Pearl Therapeutics, Morristown, New Jersey.

21. S5 Consulting, Lund, Sweden.

22. AXAR Pharmaceuticals, Corona, California.

23. National Institute for Public Health and the Environment (rivm), Bilthoven, The Netherlands.

Publisher

Mary Ann Liebert Inc

Subject

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

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