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Volumn 1, Issue 8, 2009, Pages 1415-1418

Criteria for selecting pharmacokinetic repeat study samples

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 79951771023     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/BIO.09.99     Document Type: Review
Times cited : (3)

References (9)
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    • Analytical method validation: Bioavailability, bioequivalence and pharmaceutical studies
    • Shah VP, Midha KK, Dighe SV et al.Analytical method validation: bioavailability, bioequivalence and pharmaceutical studies. Pharm. Res. 9, 588-592 (1992).
    • (1992) Pharm. Res. , vol.9 , pp. 588-592
    • Shah, V.P.1    Midha, K.K.2    Dighe, S.V.3
  • 2
    • 0028936323 scopus 로고
    • Application issues in bioanalytical method validation, sample analysis and data reporting
    • Dadgar D, Burnett PE, Choc MG et al. Application issues in bioanalytical method validation, sample analysis and data reporting. J. Pharm. Biomed. Anal. 13, 89-97 (1995)
    • (1995) J. Pharm. Biomed. Anal. , vol.13 , pp. 89-97
    • Dadgar, D.1    Burnett, P.E.2    Choc, M.G.3
  • 4
    • 0034469255 scopus 로고    scopus 로고
    • Bioanalytical method validation - A visit with a decade of progress
    • Shah VP, Midha KK, Findlay JW et al. Bioanalytical method validation - a visit with a decade of progress. Pharm. Res. 17, 1551-1557 (2000).
    • (2000) Pharm. Res. , vol.17 , pp. 1551-1557
    • Shah, V.P.1    Midha, K.K.2    Findlay, J.W.3
  • 5
    • 0003484310 scopus 로고    scopus 로고
    • US FDA, US Department of Health and Human Services. US FDA, Center for Drug Evaluation and Research, Rockville, MD, USA
    • US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services. US FDA, Center for Drug Evaluation and Research, Rockville, MD, USA (2001).
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 6
    • 79951768879 scopus 로고    scopus 로고
    • The 2nd Calibration and Validation Group Workshop on recent issues in good laboratory practice bioanalysis
    • Savoie N, Booth BP, Bradley T et al. The 2nd Calibration and Validation Group Workshop on recent issues in good laboratory practice bioanalysis. Bioanalysis 1, 19-30 (2009).
    • (2009) Bioanalysis , vol.1 , pp. 19-30
    • Savoie, N.1    Booth, B.P.2    Bradley, T.3
  • 7
    • 84906669830 scopus 로고    scopus 로고
    • US FDA. US Department of Health and Human Services. US FDA, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, MD, USA
    • US FDA. Correspondence to Aripiprazole ANDA Applicant on September 28, 2006. US Department of Health and Human Services. US FDA, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, MD, USA (2006).
    • (2006) Correspondence to Aripiprazole ANDA Applicant on September 28, 2006
  • 8
    • 33847184252 scopus 로고    scopus 로고
    • Workshop/conference report - Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
    • Viswanathan CT, Bansal S, Booth B et al. Workshop/conference report - quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9, E30-E42 (2007).
    • (2007) AAPS J. , vol.9
    • Viswanathan, C.T.1    Bansal, S.2    Booth, B.3
  • 9
    • 68249147642 scopus 로고    scopus 로고
    • Workshop report and follow-up - AAPS workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples - Implications of Crystal City recommendations
    • Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up - AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples - implications of Crystal City recommendations. AAPS J. 11, 238-241 (2009).
    • (2009) AAPS J. , vol.11 , pp. 238-241
    • Fast, D.M.1    Kelley, M.2    Viswanathan, C.T.3


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