Critical review of near-infrared spectroscopic methods validations in pharmaceutical applications.

[1]  Douglas G. Altman,et al.  Measurement in Medicine: The Analysis of Method Comparison Studies , 1983 .

[2]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[3]  Luis A. Escobar,et al.  Statistical Intervals: A Guide for Practitioners , 1991 .

[4]  D G Altman,et al.  Statistics notes: Absence of evidence is not evidence of absence , 1995 .

[5]  D. Altman,et al.  Measuring agreement in method comparison studies , 1999, Statistical methods in medical research.

[6]  P. Alderson,et al.  Absence of evidence is not evidence of absence , 2004, BMJ : British Medical Journal.

[7]  Yan-Chun Feng,et al.  Construction of universal quantitative models for determination of roxithromycin and erythromycin ethylsuccinate in tablets from different manufacturers using near infrared reflectance spectroscopy. , 2006, Journal of pharmaceutical and biomedical analysis.

[8]  G. Winter,et al.  NIR spectroscopy-a non-destructive analytical tool for protein quantification within lipid implants. , 2006, Journal of controlled release : official journal of the Controlled Release Society.

[9]  Thomas Rades,et al.  Quantification of binary polymorphic mixtures of ranitidine hydrochloride using NIR spectroscopy , 2006 .

[10]  M. P. Freitas,et al.  Multivariate analysis of nystatin and metronidazole in a semi-solid matrix by means of diffuse reflectance NIR spectroscopy and PLS regression. , 2006, Journal of pharmaceutical and biomedical analysis.

[11]  M. Blanco,et al.  A process analytical technology approach based on near infrared spectroscopy: tablet hardness, content uniformity, and dissolution test measurements of intact tablets. , 2006, Journal of pharmaceutical sciences.

[12]  M Alcalá,et al.  Simultaneous quantitation of five active principles in a pharmaceutical preparation: development and validation of a near infrared spectroscopic method. , 2006, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[13]  A Rieutord,et al.  Near infrared spectroscopy and process analytical technology to master the process of busulfan paediatric capsules in a university hospital. , 2006, Journal of pharmaceutical and biomedical analysis.

[14]  M. Blanco,et al.  Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy: A contribution to process analytical technologies , 2006 .

[15]  M Laurentie,et al.  Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II. , 2004, Journal of pharmaceutical and biomedical analysis.

[16]  L Delattre,et al.  Validation of manufacturing process of Diltiazem HCl tablets by NIR spectrophotometry (NIRS). , 2007, Journal of pharmaceutical and biomedical analysis.

[17]  Thomas Rades,et al.  Quantifying ternary mixtures of different solid-state forms of indomethacin by Raman and near-infrared spectroscopy. , 2007, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[18]  Susanne Jacobsen,et al.  Determination of aluminium content in aluminium hydroxide formulation by FT-NIR transmittance spectroscopy. , 2007, Vaccine.

[19]  Eric Ziemons,et al.  Analysis of recent pharmaceutical regulatory documents on analytical method validation. , 2007, Journal of chromatography. A.

[20]  J. Menezes,et al.  Development and validation of a method for active drug identification and content determination of ranitidine in pharmaceutical products using near-infrared reflectance spectroscopy: a parametric release approach. , 2008, Talanta.

[21]  Bingren Xiang,et al.  Quantitative determination of acyclovir in plasma by near infrared spectroscopy , 2008 .

[22]  Yan-Chun Feng,et al.  Feasibility and extension of universal quantitative models for moisture content determination in beta-lactam powder injections by near-infrared spectroscopy. , 2008, Analytica chimica acta.

[23]  Søren Balling Engelsen,et al.  Chemometric prediction of alginate monomer composition: A comparative spectroscopic study using IR, Raman, NIR and NMR , 2008 .

[24]  M. de la Guardia,et al.  Green Analytical Chemistry , 2008 .

[25]  M. Blanco,et al.  Pharmaceutical gel analysis by NIR spectroscopy. Determination of the active principle and low concentration of preservatives. , 2008, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[26]  H. M. Nielsen,et al.  NIR transmission spectroscopy for rapid determination of lipid and lyoprotector content in liposomal vaccine adjuvant system CAF01. , 2008, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[27]  The use of FT-NIR for API content assay in organic solvent media: a single calibration for multiple downstream processing streams. , 2008, Talanta.

[28]  E. Yonemochi,et al.  Development of a method for the determination of caffeine anhydrate in various designed intact tablets [correction of tables] by near-infrared spectroscopy: a comparison between reflectance and transmittance technique. , 2008, Journal of pharmaceutical and biomedical analysis.

[29]  Susanne Jacobsen,et al.  Determination of moisture content of lyophilized allergen vaccines by NIR spectroscopy. , 2008, Journal of pharmaceutical and biomedical analysis.

[30]  Henderik W Frijlink,et al.  Application of process analytical technology in tablet process development using NIR spectroscopy: blend uniformity, content uniformity and coating thickness measurements. , 2008, International journal of pharmaceutics.

[31]  R. López-Arellano,et al.  Quantification of lysine clonixinate in intravenous injections by NIR spectroscopy , 2009 .

[32]  P. Borman,et al.  Acceptance criteria for method equivalency assessments. , 2009, Analytical chemistry.

[33]  J. Mantanus,et al.  Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: method development and validation. , 2009, Analytica chimica acta.

[34]  Abhay Gupta,et al.  Real-time on-line blend uniformity monitoring using near-infrared reflectance spectrometry: a noninvasive off-line calibration approach. , 2009, Journal of pharmaceutical and biomedical analysis.

[35]  J. Lopes,et al.  Quality control of pharmaceuticals with NIR: From lab to process line , 2009 .

[36]  J. Rantanen,et al.  Role of excipients in the quantification of water in lyophilised mixtures using NIR spectroscopy. , 2009, Journal of pharmaceutical and biomedical analysis.

[37]  Huiquan Wu,et al.  Quality-by-design (QbD): an integrated multivariate approach for the component quantification in powder blends. , 2009, International journal of pharmaceutics.

[38]  E. Chapuzet,et al.  Critical analysis of several analytical method validation strategies in the framework of the fit for purpose concept. , 2010, Journal of chromatography. A.

[39]  Qiang Fu,et al.  Construction of a universal quantitative model for ibuprofen sustained-release capsules from different manufacturers using near-infrared diffuse reflection spectroscopy , 2010 .

[40]  C. Liew,et al.  In-line quantification of drug and excipients in cohesive powder blends by near infrared spectroscopy. , 2010, International journal of pharmaceutics.

[41]  Celine Valeria Liew,et al.  In-line quantification of micronized drug and excipients in tablets by near infrared (NIR) spectroscopy: Real time monitoring of tabletting process. , 2010, International journal of pharmaceutics.

[42]  J. Mantanus,et al.  Acetaminophen determination in low-dose pharmaceutical syrup by NIR spectroscopy. , 2010, Journal of pharmaceutical and biomedical analysis.

[43]  M. Blanco,et al.  Influence of physical factors on the accuracy of calibration models for NIR spectroscopy. , 2010, Journal of pharmaceutical and biomedical analysis.

[44]  Eric Ziemons,et al.  Quantitative analysis using near infrared spectroscopy, Application to tablet content uniformity, I. Methodology , 2010 .

[45]  Miguel de la Guardia,et al.  Vibrational spectroscopy provides a green tool for multi-component analysis , 2010 .

[46]  Yan Song,et al.  Near-infrared spectroscopy quantitative determination of pefloxacin mesylate concentration in pharmaceuticals by using partial least squares and principal component regression multivariate calibration. , 2010, Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy.

[47]  Hiroshi Teramoto,et al.  Development of a method for nondestructive NIR transmittance spectroscopic analysis of acetaminophen and caffeine anhydrate in intact bilayer tablets. , 2010, Journal of pharmaceutical and biomedical analysis.

[48]  Aditya U. Vanarase,et al.  Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy , 2010 .

[49]  Limin Fang,et al.  Application of near infrared spectroscopy for rapid analysis of intermediates of Tanreqing injection. , 2010, Journal of pharmaceutical and biomedical analysis.

[50]  Alan G. Ryder,et al.  Quantitative analysis of sulfathiazole polymorphs in ternary mixtures by attenuated total reflectance infrared, near-infrared and Raman spectroscopy. , 2010, Journal of pharmaceutical and biomedical analysis.

[51]  Jérôme Mantanus,et al.  Building the quality into pellet manufacturing environment--feasibility study and validation of an in-line quantitative near infrared (NIR) method. , 2010, Talanta.

[52]  Marcelo Blanco,et al.  Analysis of pharmaceuticals by NIR spectroscopy without a reference method , 2010 .

[53]  M. Blanco,et al.  Controlling individual steps in the production process of paracetamol tablets by use of NIR spectroscopy. , 2010, Journal of pharmaceutical and biomedical analysis.

[54]  J. Mantanus,et al.  Active content determination of non-coated pharmaceutical pellets by near infrared spectroscopy: method development, validation and reliability evaluation. , 2010, Talanta.

[55]  Jukka Rantanen,et al.  Towards a robust water content determination of freeze-dried samples by near-infrared spectroscopy. , 2010, Analytica chimica acta.

[56]  Construction of predictive models for gentamicin contents in aqueous solution using specific near infrared spectral regions , 2011 .

[57]  Loïc Meunier,et al.  Tablet potency of Tianeptine in coated tablets by near infrared spectroscopy: model optimisation, calibration transfer and confidence intervals. , 2011, Journal of pharmaceutical and biomedical analysis.

[58]  T. Saffaj,et al.  Uncertainty profiles for the validation of analytical methods. , 2011, Talanta.

[59]  M. Blanco,et al.  NIR analysis of pharmaceutical samples without reference data: improving the calibration. , 2011, Talanta.

[60]  O. Kvalheim,et al.  Multivariate data analysis in pharmaceutics: a tutorial review. , 2011, International journal of pharmaceutics.

[61]  A. Peinado,et al.  Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product. , 2011, Journal of pharmaceutical and biomedical analysis.

[62]  E. Rozet,et al.  Near infrared and Raman spectroscopy as Process Analytical Technology tools for the manufacturing of silicone-based drug reservoirs. , 2011, Analytica chimica acta.

[63]  Dongsheng Bu,et al.  Comparison of near infrared and microwave resonance sensors for at-line moisture determination in powders and tablets. , 2011, Analytica chimica acta.

[64]  R. Marini,et al.  Comments on "uncertainty profiles for the validation of analytical methods" by Saffaj and Ihssane. , 2012, Talanta: The International Journal of Pure and Applied Analytical Chemistry.