Equivalence of complex drug products: advances in and challenges for current regulatory frameworks-Reference-Cited by-同舟云学术

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Published:2017-04-26 Issue:1 Volume:1407 Page:39-49
ISSN:0077-8923
Container-title:Annals of the New York Academy of Sciences
language:en
Short-container-title:Ann. N.Y. Acad. Sci.

Author:

Hussaarts Leonie¹,Mühlebach Stefan²,Shah Vinod P.³,McNeil Scott⁴,Borchard Gerrit⁵,Flühmann Beat²,Weinstein Vera⁶,Neervannan Sesha⁷,Griffiths Elwyn⁸,Jiang Wenlei⁹,Wolff-Holz Elena¹⁰,Crommelin Daan J.A.¹¹,de Vlieger Jon S.B.¹

Affiliation:

1. Lygature; Utrecht the Netherlands

2. Vifor Pharma Ltd.; Glattbrugg Switzerland

3. Pharmaceutical Consultant; North Potomac Maryland

4. Nanotechnology Characterization Laboratory; Frederick Maryland

5. University of Geneva-University of Lausanne; Geneva Switzerland

6. Teva Pharmaceuticals; Petach Tikva Israel

7. Allergen Plc; Irvine California

8. Member of the WHO Advisory Panel on Biological Standardization; Kingston upon Thames; Surrey United Kingdom

9. United States Food and Drug Administration; Silver Spring Maryland

10. Paul Ehrlich Institute; Langen Germany

11. Utrecht University; Utrecht the Netherlands

Publisher

Wiley

Subject

History and Philosophy of Science,General Biochemistry, Genetics and Molecular Biology,General Neuroscience

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/nyas.13347/fullpdf

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5. Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan;Shibata;AAPS Open,2016

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