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Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products

2019 ◽  
Vol 20 (6) ◽  
Author(s):  
Marcia Cavallin Silva ◽  
Helena Silveira Costa ◽  
Bruna Nardy Valadares ◽  
Leticia Grecchi ◽  
Lee Nagao ◽  
...  
Keyword(s):  
Therapeutic Equivalence ◽  
Drug Products ◽  
Nasal Drug Products

European Regulatory Developments for Orally Inhaled and Nasal Drug Products

2018 ◽  
Vol 19 (7) ◽  
pp. 3134-3140 ◽  
Author(s):  
Carlos Santos ◽  
Gustavo Marco ◽  
Lee M. Nagao ◽  
Eva Castro ◽  
Tim Chesworth
Keyword(s):  
Drug Products ◽  
European Regulatory ◽  
Nasal Drug Products

Risk Management for Materials and Components Used in Orally Inhaled and Nasal Drug Products

2015 ◽  
Vol 33 (1) ◽  
pp. 1-17 ◽  
Author(s):  
Cheryl L. M. Stults ◽  
Gaby Reckzuegel ◽  
Arthur Bailey ◽  
Jonathan Petersen ◽  
Lisa Dick ◽  
...  
Keyword(s):  
Risk Management ◽  
Drug Products ◽  
Nasal Drug Products

scholarly journals Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference

2015 ◽  
Vol 17 (5) ◽  
pp. 1305-1311 ◽  
Author(s):  
Guenther Hochhaus ◽  
Craig Davis-Cutting ◽  
Martin Oliver ◽  
Sau L. Lee ◽  
Svetlana Lyapustina
Keyword(s):  
University Of Florida ◽  
Drug Products ◽  
Nasal Drug Products

scholarly journals Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

Pharmaceutics ◽  
2014 ◽  
Vol 6 (2) ◽  
pp. 195-219 ◽  
Author(s):  
Sabrina Trows ◽  
Klaus Wuchner ◽  
Rene Spycher ◽  
Hartwig Steckel
Keyword(s):  
Regulatory Requirements ◽  
Drug Products ◽  
Nasal Drug Products ◽  
The U.S
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