Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation

Toxicological Sciences

Volumn 97, Issue 2, 2007, Pages 226-236

  Ball, Douglas ^a   Blanchard, James ^b   Jacobson Kram, David ^c   McClellan, Roger O ^d   McGovern, Timothy ^c   Norwood, Daniel L ^e   Vogel, W Mark ^a   Wolff, Ron ^f   Nagao, Lee ^g  

^a PFIZER INC   (United States)

^b ARADIGM CORPORATION   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^e BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^f NEKTAR THERAPEUTICS   (United States)

^g LLP   (United States)

Author keywords

Extractables; Inhalation; Leachables; Nasal; PQRI; Qualification threshold; Safety concern threshold

Indexed keywords

ACENAPHTHENE DERIVATIVE; DRUG; FORMALDEHYDE; NITROGEN DIOXIDE; NITROSAMINE; SEBACIC ACID; SULFONAMIDE; SULFUR DIOXIDE; SULFURIC ACID; TOLUENE; TOLUENE DIISOCYANATE;

ASTHMA; CHRONIC BRONCHITIS; CONSUMER; DATA BASE; DIABETES MELLITUS; DRUG APPROVAL; DRUG INDUSTRY; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HUMAN; LUNG DISEASE; ORGANIZATION; REVIEW; RISK ASSESSMENT; SYSTEMIC DISEASE; UNITED STATES;

ADMINISTRATION, INHALATION; ADMINISTRATION, INTRANASAL; ANIMALS; HUMANS; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34447556889     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfm058     Document Type: Review

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