Uniformity of dosage units using large sample sizes

Pharmaceutical Technology

Volumn 36, Issue 10, 2012, Pages 118-122

  Holte, O ^a   Horvat, M ^b  

^a Norwegian Medicines Agency   (Norway)

^b European Pharmacopoeia ^*  (France)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; BATCH PROCESS; DOSE CALCULATION; DRUG APPROVAL; DRUG CONTROL; DRUG DOSAGE FORM; DRUG INDUSTRY; DRUG QUALITY; HUMAN; PHARMACEUTICS; POWDER; PRACTICE GUIDELINE; QUALITY BY DESIGN; QUALITY CONTROL; SAMPLE SIZE; STANDARD;

EID: 84870044417     PISSN: 15432521     EISSN: 21507376     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Ph.Eur., General Chapter 2.9.40 Uniformity of Dosage Units (European Pharmacopeia, Council of Europe, France).
2. USP, General Chapter <905> Uniformity of Dosage Units (US Pharmacopeial Convention, Rockville, Maryland).
3. See P h. E u r. Dosage Form Monographs (e.g., ).
4. J. Limberg and M. Savsek, Pharmeuropa Scientific Notes 2, 45-48 (2006).
5. D. Sandell et al., Drug Information Jrnl. 40 337-34 4 (2006).
6. M. Diener et al., Drug Information Jrnl. 43 287-298 (2009).
7. L. Foust et al., Pharm. Technol. 31 (9) 108-115 (2007).
8. J.R. Murphy and K.L. Griffiths, Pharm. Technol. 30 (1) 52-60 92006).
9. J. Bergum and K.E. Vukovinsky, Pharm. Technol. 34 (11) 72-79 (2010).
10. Ø. Holte and M. Horvat, Pharmeuropa 23.2, 286-293 (2011). PT