Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal - Part I

Journal of Pharmaceutical and Biomedical Analysis

Volumn 36, Issue 3, 2004, Pages 579-586

  Hubert, Ph ^a   Nguyen Huu, J J ^b   Boulanger, B ^c   Chapuzet, E ^d   Chiap, P ^a   Cohen, N ^e   Compagnon, P A ^f   Dewe W ^c   Feinberg, M ^g   Lallier, M ^h   Laurentie, M ⁱ   Mercier, N ^d   Muzard, G ^j   Nivet, C ^k   Valat, L ^l  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b SANOFI   (France)

^c Development Centre

^d Qualilab   (France)

^e Expanscience   (France)

^f Boulevard Anatole France   (France)

^g BICHAT HOSPITAL   (France)

^h INNOTHERA   (France)

ⁱ BP 203 F 35032 F   (France)

^j MERCK THERAMEX   (Monaco)

^k CERB   (France)

^l Viatris Inc   (France)

more..

Author keywords

Analytical procedure; Harmonization; Quantitative analysis; Validation; Expectation tolerance interval

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL ERROR; DOCUMENTATION; DRUG RESEARCH; METHODOLOGY; ORGANIZATION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVIEW; STATISTICAL ANALYSIS; TECHNIQUE; VALIDATION PROCESS;

EID: 7444240202     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2004.07.027     Document Type: Article

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