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Chromatographia

Volumn 73, Issue 3-4, 2011, Pages 201-217

International guidelines for bioanalytical method validation: A comparison and discussion on current scenario

(5) Kollipara, Sivacharan a Bende, Girish b Agarwal, Nitin a Varshney, Brijesh a Paliwal, Jyoti a

a RANBAXY RESEARCH LABORATORIES (India)

b BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCE (India)

Author keywords

ANVISA; Bioanalysis; EMA; Regulatory guidance; US FDA; Validation

Indexed keywords

ANTICOAGULANT AGENT;

ANALYTIC METHOD; BIOASSAY; BLOOD; CALIBRATION; DILUTION; FOOD AND DRUG ADMINISTRATION; HEMOLYSIS; HYPERLIPIDEMIA; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MATHEMATICAL MODEL; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; REVIEW; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 79951774415 PISSN: 00095893 EISSN: 16121112 Source Type: Journal
DOI: 10.1007/s10337-010-1869-2 Document Type: Review

Times cited : (73)

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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.