Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey-Reference-Cited by-同舟云学术

Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey

Published:2017-11 Issue:1 Volume:1407 Page:26-38
ISSN:0077-8923
Container-title:Annals of the New York Academy of Sciences
language:en
Short-container-title:Ann. N.Y. Acad. Sci.

Author:

Oner Z. Gulsen¹²,Michel Sarah L.J.¹,Polli James E.¹

Affiliation:

1. Department of Pharmaceutical Sciences; University of Maryland; Baltimore Maryland

2. Turkish Medicines and Medical Devices Agency; Ankara Turkey

Funder

U.S. Food and Drug Administration

Turkish Medicines and Medical Devices Agency

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.13505/fullpdf

Reference44 articles.

1. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks;Hussaarts;Ann. N.Y. Acad. Sci.,2017

2. U.S. Food & Drug Administration 2014 About the center for drug evaluation and research https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm

3. U.S. Food & Drug Administration 2017 Office of generic drugs https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm119100.htm

4. U.S. Food & Drug Administration 2017 Office of New Drugs https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184426.htm

5. European Medicines Agency 2017 About us http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/08/WC500211862.pdf

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