Development of a content uniformity test suitable for large sample sizes

Drug Information Journal

Volumn 40, Issue 3, 2006, Pages 337-344

  Sandell, Dennis ^a   Vukovinsky, Kim ^b   Diener, Myron ^c   Hofer, Jeff ^d   Pazdan, James ^e   Timmermans, Joep ^b  

^a ASTRAZENECA R AND D   (Sweden)

^b PFIZER INC   (United States)

^c Sanofi Aventis Group   (United States)

^d ELI LILLY AND COMPANY   (United States)

^e NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Counting test; Coverage; Process analytical technology (PAT); Specification; Uniformity of dosage units (UDU)

Indexed keywords

ANALYTIC METHOD; CALCULATION; CONTENT ANALYSIS; CONTENT UNIFORMITY TEST; DATA ANALYSIS; DATA SYNTHESIS; EVALUATION; HUMAN; MATHEMATICAL ANALYSIS; MEDICAL LITERATURE; NONPARAMETRIC TEST; PRIORITY JOURNAL; PROBABILITY; PROCESS ANALYTICAL TECHNOLOGY; REVIEW; SAMPLE SIZE;

EID: 33747616460     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150604000312     Document Type: Review

References (1)

1. 〈905〉United States Pharmacopeia Convention. Uniformity of dosage units. In: United States Pharmacopeia. Rockville, MD: United States Pharmacopeia Convention; 2005:2505-2510.