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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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
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container_end_page 479
container_issue 3
container_start_page 471
container_title Pharmaceutical research
container_volume 24
creator 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
description 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.
doi_str_mv 10.1007/s11095-006-9172-5
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ispartof Pharmaceutical research, 2007-03, Vol.24 (3), p.471-479
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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
title Best practices for managing quality and safety of foreign particles in orally inhaled and nasal drug products, and an evaluation of clinical relevance
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