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Volumn 10, Issue 1, 2007, Pages 120-124

Methodology for NIR identification of pharmaceutical finished products with emphasis on negative controls and data driven threshold value selection

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DOSAGE FORM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SCREENING; FILM COATING; NEAR INFRARED SPECTROSCOPY; PRACTICE GUIDELINE; SHORT SURVEY;

EID: 40949120776     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey
Times cited : (3)

References (12)
  • 1
    • 55549142627 scopus 로고    scopus 로고
    • Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances, ICH Harmonised Tripartite Guideline (ICH Q6A)
    • "Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances", ICH Harmonised Tripartite Guideline (ICH Q6A)
  • 3
    • 0006424626 scopus 로고    scopus 로고
    • Use of Near-Infrared Spectroscopy (NIRS) for Qualitative Analysis of Pharmaceutical Raw Materials and Dosage Forms
    • Forbess, R.A. & Shukla, A.J. Use of Near-Infrared Spectroscopy (NIRS) for Qualitative Analysis of Pharmaceutical Raw Materials and Dosage Forms, American Pharmaceutical Review 1998; 1(1): 67.
    • (1998) American Pharmaceutical Review , vol.1 , Issue.1 , pp. 67
    • Forbess, R.A.1    Shukla, A.J.2
  • 5
    • 0035171358 scopus 로고    scopus 로고
    • One Hundred Percent Identity Check of Pharmaceutical Products by Near-Infrared Spectroscopy on the Packaging Line
    • Herkert, T.; Prinz, H.; & Kovar, K.A. "One Hundred Percent Identity Check of Pharmaceutical Products by Near-Infrared Spectroscopy on the Packaging Line", European Journal of Pharmaceutics and Biopharmaceutics, 2001; 51:9-16.
    • (2001) European Journal of Pharmaceutics and Biopharmaceutics , vol.51 , pp. 9-16
    • Herkert, T.1    Prinz, H.2    Kovar, K.A.3
  • 6
    • 55549085965 scopus 로고    scopus 로고
    • Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharamcetuical Industry and the Data Requirements for New Submissions and Variations, EMEA Guidelines, Adoption Date: Feb 2003
    • "Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharamcetuical Industry and the Data Requirements for New Submissions and Variations", EMEA Guidelines, Adoption Date: Feb 2003
  • 7
    • 0141680264 scopus 로고    scopus 로고
    • Validation of NIR Qualitative Identification Methods for the Pharmaceutical Industry
    • Anderson, C. "Validation of NIR Qualitative Identification Methods for the Pharmaceutical Industry", American Pharmaceutical Review, 2000; 3(1), 30-42.
    • (2000) American Pharmaceutical Review , vol.3 , Issue.1 , pp. 30-42
    • Anderson, C.1
  • 8
    • 0242332309 scopus 로고    scopus 로고
    • Content Uniformity Testing with Near Infrared Spectroscopy
    • Romanach, R. J. & Santos, M. A. "Content Uniformity Testing with Near Infrared Spectroscopy", American Pharmaceutical Review, 2003, 6 (2): 62-67.
    • (2003) American Pharmaceutical Review , vol.6 , Issue.2 , pp. 62-67
    • Romanach, R.J.1    Santos, M.A.2
  • 9
    • 0038082475 scopus 로고    scopus 로고
    • A Statistical Support for Using Spectroscopic Methods to Validate the Content Uniformity of Solid Dosage Forms
    • Li, T.; Donner, A. D.; Choi, C. Y.; Frunzi, G. P.; & Morris, K. R. "A Statistical Support for Using Spectroscopic Methods to Validate the Content Uniformity of Solid Dosage Forms", Journal of Pharmaceutical Sciences, 2003, 92 (7): 1526-1530.
    • (2003) Journal of Pharmaceutical Sciences , vol.92 , Issue.7 , pp. 1526-1530
    • Li, T.1    Donner, A.D.2    Choi, C.Y.3    Frunzi, G.P.4    Morris, K.R.5
  • 10
    • 0036575606 scopus 로고    scopus 로고
    • Chemometric Quantitation of the Active Substance (Containing C?N) in a Pharmaceutical Tablet Using Near-Infrared (NIR) Transmittance and NIR FT-Raman Spectroscopy
    • Dyrby, M.; Engelsen, S. B.; NØrgaard, L.; Bruhn, M.; & Lundsberg-Nielsen, L. "Chemometric Quantitation of the Active Substance (Containing C?N) in a Pharmaceutical Tablet Using Near-Infrared (NIR) Transmittance and NIR FT-Raman Spectroscopy" Applied Spectroscopy, (2002), 56:579-585.
    • (2002) Applied Spectroscopy , vol.56 , pp. 579-585
    • Dyrby, M.1    Engelsen, S.B.2    NØrgaard, L.3    Bruhn, M.4    Lundsberg-Nielsen, L.5
  • 11
    • 55549103103 scopus 로고    scopus 로고
    • Considerations for Development of Tablet Content Uniformity Measurements by Near-IR Spectrometry
    • 15 November
    • John, C. T.; Pixley, N. C.; Guenard, R.; & Green, R. L. "Considerations for Development of Tablet Content Uniformity Measurements by Near-IR Spectrometry", EAS Annual Symposium, 15 November 2005.
    • (2005) EAS Annual Symposium
    • John, C.T.1    Pixley, N.C.2    Guenard, R.3    Green, R.L.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.