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Volumn 49, Issue 1, 2009, Pages 48-54

Real-time on-line blend uniformity monitoring using near-infrared reflectance spectrometry: A noninvasive off-line calibration approach

Author keywords

Blend uniformity; Near infrared; Off line calibration; Partial least squares; Pharmaceutical

Indexed keywords

CROSPOVIDONE; LACTOSE; MICROCRYSTALLINE CELLULOSE;

EID: 58249125677     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.10.001     Document Type: Article
Times cited : (83)

References (20)
  • 1
    • 58249125206 scopus 로고    scopus 로고
    • US Food and Drugs Administration, Guidance for industry powder blends and finished dosage units-stratified in-process dosage unit sampling and assessment, Draft Guidance, www.fda.gov (2003).
    • US Food and Drugs Administration, Guidance for industry powder blends and finished dosage units-stratified in-process dosage unit sampling and assessment, Draft Guidance, www.fda.gov (2003).
  • 5
    • 58249144941 scopus 로고    scopus 로고
    • PAT-a framework for innovative pharmaceutical manufacturing and quality assurance, in: Center for Drug Development and Research (U.S. Food and Drug Administration, Rockville, MD, 2004).
    • PAT-a framework for innovative pharmaceutical manufacturing and quality assurance, in: Center for Drug Development and Research (U.S. Food and Drug Administration, Rockville, MD, 2004).
  • 17
    • 58249125887 scopus 로고    scopus 로고
    • ICH Guidelines, Q2B, Validation of analytical procedures: methodology, the Federal Registrar. Vol. 62: 27463-27467, No. 96 (1997).
    • ICH Guidelines, Q2B, Validation of analytical procedures: methodology, the Federal Registrar. Vol. 62: 27463-27467, No. 96 (1997).
  • 20
    • 0031413466 scopus 로고    scopus 로고
    • J. Berman, D.E. Elinski, C.R. Gonzales, J.D. Hofer, P.J. Jimenez, J.A. Planchard, R.J. Tlachac, P.F. Vogel, Blend uniformity analysis: validation and in-process testing, PDA Technical Report No. 25, 1997, pp. 51:S51-S99.
    • J. Berman, D.E. Elinski, C.R. Gonzales, J.D. Hofer, P.J. Jimenez, J.A. Planchard, R.J. Tlachac, P.F. Vogel, Blend uniformity analysis: validation and in-process testing, PDA Technical Report No. 25, 1997, pp. 51:S51-S99.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.