Bioequivalence for Orally Inhaled and Nasal Drug Products

2014 ◽  
pp. 369-394 ◽  
Author(s):  
Bhawana Saluja ◽  
Bing V. Li ◽  
Sau L. Lee
Keyword(s):  
Drug Products ◽  
Nasal Drug Products

Higher Yield and Quality through Particle Identification

2008 ◽  
Vol 51 (2) ◽  
pp. 55-65
Author(s):  
O. Valet ◽  
M. Lankers
Keyword(s):  
Rapid Determination ◽  
Particle Identification ◽  
Manufacturing Processes ◽  
Data Sets ◽  
Drug Products ◽  
Particulate Contamination ◽  
Yield And Quality ◽  
Analytical Result ◽  
Nasal Drug Products

The sources of particulate contamination are often not easy to identify. To control manufacturing processes, the measurement of particle concentration and size is necessary and has been routinely performed for many years. Technology has been developed to increase the information available for the immediate evaluation of particles. The method analyzes airborne particles or particles isolated from liquids automatically according to their number, size, and chemical composition.1,2 The analysis of thousands of particles enables users to locate the major sources of contamination in various manufacturing processes. The analytical tool provides rapid determination of particulate contamination, thus allowing for a quick, efficient response. Over time, the ability to compare analytical result data sets assists in detecting trends and implementing the appropriate quality management. Routine use of the technology contributes to ongoing supervision and optimization of production processes. This study reports on the use of the technology to analyze foreign particles associated with oral, inhalable, and nasal drug products (OINDP), parenterals, and coronary stents. Applications for troubleshooting and identifying latent contamination sources are discussed through several examples.

Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations

2008 ◽  
Vol 25 (4) ◽  
pp. 727-739 ◽  
Author(s):  
Daniel L. Norwood ◽  
Diane Paskiet ◽  
Michael Ruberto ◽  
Thomas Feinberg ◽  
Alan Schroeder ◽  
...  
Keyword(s):  
Best Practices ◽  
Drug Products ◽  
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 Non-impactor-Based Methods for Sizing of Aerosols Emitted from Orally Inhaled and Nasal Drug Products (OINDPs)

2011 ◽  
Vol 12 (3) ◽  
Author(s):  
Jolyon Mitchell ◽  
Richard Bauer ◽  
Svetlana Lyapustina ◽  
Terrence Tougas ◽  
Volker Glaab
Keyword(s):  
Drug Products ◽  
Nasal Drug Products

Overview of Leachables and Extractables in Orally Inhaled and Nasal Drug Products

2012 ◽  
pp. 1-19
Author(s):  
Douglas J. Ball ◽  
Daniel L. Norwood ◽  
Lee M. Nagao
Keyword(s):  
Drug Products ◽  
Nasal Drug Products
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