(Q28204730)

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Guidance for robustness/ruggedness tests in method validation

scientific article (publication date: March 2001)

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title

Guidance for robustness/ruggedness tests in method validation (English)

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author name string

Y Vander Heyden

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1

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A Nijhuis

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2

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J Smeyers-Verbeke

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3

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B G Vandeginste

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4

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D L Massart

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5

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English

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publication date

March 2001

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published in

Journal of Pharmaceutical and Biomedical Analysis

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volume

24

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issue

5-6

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page(s)

723-53

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cites work

RES, an expert system for the set-up and interpretation of a ruggedness test in HPLC method validation

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Ruggedness testing of chromatographic methods: selection of factors and levels

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Application issues in bioanalytical method validation, sample analysis and data reporting

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Robustness testing in liquid chromatography and capillary electrophoresis

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A ruggedness test strategy for procedure related factors: experimental set-up and interpretation

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Ruggedness tests on the high performance liquid chromatography assay of the United States Pharmacopoeia 23 for tetracycline.HCl: comparison of different columns in an interlaboratory approach

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7 January 2021

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Ruggedness testing of a size-exclusion chromatographic assay for low-molecular-mass polymers

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Identifiers

DOI

10.1016/S0731-7085(00)00529-X

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PubMed publication ID

11248467

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(Q28204730)

Guidance for robustness/ruggedness tests in method validation

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