ANVISA: an introduction to a new regulatory agency with many challenges

AAPS Open - 2018
Kim Huynh‐Ba1, Alexandra B. Sassi2
1Pharmalytik LLC, Newark, DE, USA
2Voisin Consulting Life Sciences, Cambridge, MA, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

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ANVISA Resolution RDC No 45, regulates the conductance of studies on active pharmaceutical ingredients stability, 9, 2012

ANVISA Resolution RE (2005) No 1, guide for the undertaking of stability. Studies

Moraes do Carmo AC, Pereira RS, Gratieri T (2017) Brazilian requirements for stability indicating methods, science direct, trends in analytical chemistry. Elsevier

Nagao L., et al., n.d. A comparison of Brazil ANVISA and ICH Stability Requirements for Inhalation Products, https://ipacrs.org , https://ipacrs.org/assets/uploads/outputs/Brazil_poster.pdf

Reuters T (2014) Reformatting Your CTD Information for Your Brazilian Registration Dossier. http://citeseerx.ist.psu.edu/viewdoc/download;jsessionid=BAB8867A2ED27A92D789E35CE7EB491B?doi=10.1.1.676.2134&rep=rep1&type=pdf

Tattersall P et al (2016) Impact from the recent issuance of ANVISA resolution RDC-53/2015 on pharmaceutical small molecule forced degradation study requirements. American Pharmaceutical Review 31 https://www.americanpharmaceuticalreview.com/Featured-Articles/184364-Impact-from-the-Recent-Issuance-of-ANVISA-Resolution-RDC-53-2015-on-Pharmaceutical-Small-Molecule-Forced-Degradation-Study-Requirements/