A Novel Simulation-Based Approach for Comparing the Population Against Average Bioequivalence Statistical Test for the Evaluation of Nasal Spray Products on Spray Pattern and Droplet Size Distribution Parameters-Reference-Cited by-同舟云学术

A Novel Simulation-Based Approach for Comparing the Population Against Average Bioequivalence Statistical Test for the Evaluation of Nasal Spray Products on Spray Pattern and Droplet Size Distribution Parameters

Published:2019-01 Issue:1 Volume:20 Page:
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Grmaš Jernej,Lužar-Stiffler Vesna,Dreu Rok,Injac Rade

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/article/10.1208/s12249-018-1223-9/fulltext.html

Reference30 articles.

1. US Food and Drug Administration. Guidance for industry. Bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. 2003. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070111.pdf . Accessed 13 Aug 2018.

2. European Medicines Agency. Guideline on the pharmaceutical quality of inhalation and nasal products (emea/chmp/qwp/49313/2005corr). 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003568.pdf . Accessed 13 Aug 2018.

3. Therapeutic Goods Administration. Guidance 19: inhalation and nasal medicines. 2013. https://www.tga.gov.au/file/5212/download . Accessed 13 Aug 2018.

4. Health Canada. Guidance for industry pharmaceutical quality of inhalation and nasal products. 2006. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/inhalationnas-eng.pdf . Accessed 13 Aug 2018.

5. ANVISA Brazil National Health Surveillance Agency. Nota técnica n° 01 de 2013 - cefar-gtfar-ggmed-anvisa (versão 1.1). 2013. http://portal.anvisa.gov.br/documents/33836/349757/Nota+t%C3%A9cnica+n%C2%BA+01+de+2013+-+CEFAR-GTFAR-GGMED-Anvisa/a89c47fd-2558-4659-88ff-95b35a004895 . Accessed 13 Aug 2018.

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