Best practices for managing quality and safety of foreign particles in orally inhaled and nasal drug products, and an evaluation of clinical relevance

In a previous paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) outlined the progression of regulatory recommendations for foreign particles in orally inhaled and nasal drug products (OINDP), techniques for evaluating foreign particles, and proposed appro...

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Bibliographic Details
Published in:Pharmaceutical research 2007-03, Vol.24 (3), p.471-479
Main Authors: Blanchard, James, Coleman, James, Crim, Courtney, Dabreu-Hayling, Claire, Fries, Lou, Ghaderi, Raouf, Haeberlin, Barbara, Malcolmson, Richard, Mittelman, Stanley, Nagao, Lee, Saracovan, Ilie, Shtohryn, Liuda, Snodgrass-Pilla, Caesar, Sundahl, Mikael, Wolff, Ronald
Format: Article
Language:English
Subjects:
Administration, Inhalation
Administration, Intranasal
Aerosols
Best practice
Drug Contamination - prevention & control
Drug-Related Side Effects and Adverse Reactions - chemically induced
Drug-Related Side Effects and Adverse Reactions - prevention & control
Humans
Particle Size
Patient safety
Pharmaceutical industry
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - chemistry
Quality Control
R&D
Regulation
Research & development
Respiratory therapy
Citations: Items that this one cites
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Summary:In a previous paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) outlined the progression of regulatory recommendations for foreign particles in orally inhaled and nasal drug products (OINDP), techniques for evaluating foreign particles, and proposed approaches for developing safety thresholds for such particles). This paper we expand on some of the key ideas proposed in that first article.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-006-9172-5