Validation of Raman spectroscopic procedures in agreement with ICH guideline Q2 with considering the transfer to real time monitoring of an active coating process

Journal of Pharmaceutical and Biomedical Analysis

Volumn 53, Issue 4, 2010, Pages 884-894

  Müller, Joshua ^a   Knop, Klaus ^a   Wirges, Markus ^a   Kleinebudde, Peter ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

Active coating; Inline measurements; Process analytical technology; Raman spectroscopy; Real time monitoring; Validation

Indexed keywords

DIPROPHYLLINE; PLACEBO;

ARTICLE; DRUG COATING; MONITORING; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RAMAN SPECTROMETRY; STATISTICAL MODEL; VALIDATION STUDY;

DYPHYLLINE; GUIDELINES AS TOPIC; LEAST-SQUARES ANALYSIS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTRUM ANALYSIS, RAMAN; TABLETS; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS;

EID: 77955566160     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.06.016     Document Type: Article

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