PMID- 22893253
OWN - NLM
STAT- MEDLINE
DCOM- 20130422
LR  - 20211021
IS  - 1573-904X (Electronic)
IS  - 0724-8741 (Print)
IS  - 0724-8741 (Linking)
VI  - 29
IP  - 12
DP  - 2012 Dec
TI  - Uncertainty estimates of purity measurements based on current information: toward 
      a "live validation" of purity methods.
PG  - 3404-19
LID - 10.1007/s11095-012-0836-z [doi]
AB  - PURPOSE: To predict precision and other performance characteristics of 
      chromatographic purity methods, which represent the most widely used form of 
      analysis in the biopharmaceutical industry. METHODS: We have conducted a 
      comprehensive survey of purity methods, and show that all performance 
      characteristics fall within narrow measurement ranges. This observation was used 
      to develop a model called Uncertainty Based on Current Information (UBCI), which 
      expresses these performance characteristics as a function of the signal and noise 
      levels, hardware specifications, and software settings. RESULTS: We applied the 
      UCBI model to assess the uncertainty of purity measurements, and compared the 
      results to those from conventional qualification. We demonstrated that the UBCI 
      model is suitable to dynamically assess method performance characteristics, based 
      on information extracted from individual chromatograms. CONCLUSIONS: The model 
      provides an opportunity for streamlining qualification and validation studies by 
      implementing a "live validation" of test results utilizing UBCI as a concurrent 
      assessment of measurement uncertainty. Therefore, UBCI can potentially mitigate 
      the challenges associated with laborious conventional method validation and 
      facilitates the introduction of more advanced analytical technologies during the 
      method lifecycle.
FAU - Apostol, Izydor
AU  - Apostol I
AD  - Amgen, Analytical Sciences, Thousand Oaks, California 91320, USA. 
      iapostol@amgen.com
FAU - Kelner, Drew
AU  - Kelner D
FAU - Jiang, Xinzhao Grace
AU  - Jiang XG
FAU - Huang, Gang
AU  - Huang G
FAU - Wypych, Jette
AU  - Wypych J
FAU - Zhang, Xin
AU  - Zhang X
FAU - Gastwirt, Jessica
AU  - Gastwirt J
FAU - Chen, Kenneth
AU  - Chen K
FAU - Fodor, Szilan
AU  - Fodor S
FAU - Hapuarachchi, Suminda
AU  - Hapuarachchi S
FAU - Meriage, Dave
AU  - Meriage D
FAU - Ye, Frank
AU  - Ye F
FAU - Poppe, Leszek
AU  - Poppe L
FAU - Szpankowski, Wojciech
AU  - Szpankowski W
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20120815
PL  - United States
TA  - Pharm Res
JT  - Pharmaceutical research
JID - 8406521
SB  - IM
MH  - Chromatography/*methods
MH  - Models, Chemical
MH  - Models, Statistical
MH  - Software
MH  - *Uncertainty
PMC - PMC3497960
EDAT- 2012/08/16 06:00
MHDA- 2013/04/23 06:00
PMCR- 2012/08/15
CRDT- 2012/08/16 06:00
PHST- 2012/01/05 00:00 [received]
PHST- 2012/07/13 00:00 [accepted]
PHST- 2012/08/16 06:00 [entrez]
PHST- 2012/08/16 06:00 [pubmed]
PHST- 2013/04/23 06:00 [medline]
PHST- 2012/08/15 00:00 [pmc-release]
AID - 836 [pii]
AID - 10.1007/s11095-012-0836-z [doi]
PST - ppublish
SO  - Pharm Res. 2012 Dec;29(12):3404-19. doi: 10.1007/s11095-012-0836-z. Epub 2012 Aug 
      15.