Content uniformity and dose uniformity: current approaches, statistical analyses, and presentation of an alternative approach, with special reference to oral inhalation and nasal drug products.
This article reviews current and proposed approaches to content uniformity testing. In addition, the article proposes an approach that allows regulatory agencies and compendia to clearly state allowable consumer risk. Further, the article suggests that producers be allowed to control producer risk through selection of numbers of units and testing tiers. The approach facilitates risk communication to practitioners and patients/consumers, which is impeded with current approaches, and reduces regulatory and compendial burden.
Williams
Roger L
RL
US Pharmacopeia, Rockville, Maryland 20852, USA.
Adams
Wallace P
WP
Poochikian
Guirag
G
Hauck
Walter W
WW
D000280:Administration, Inhalation; D000281:Administration, Intranasal; D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D004304:Dosage Forms / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data*; D006801:Humans
D004304:Dosage Forms