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Drug Development and Industrial Pharmacy Volume 22, 1996 - Issue 9-10
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Research Article

An Evaluation of a Unit-Dose Compacting Sample Thief and a Discussion of Content Uniformity Testing and Blending Validation Issues

Rong-Kun Chang The DuPont Merck Pharmaceutical Company, Experimental Station, PO Box 80400, Wilmington, Delaware, 19880-0400
,
Jayant Shukla The DuPont Merck Pharmaceutical Company, Experimental Station, PO Box 80400, Wilmington, Delaware, 19880-0400
&
John Buehler The DuPont Merck Pharmaceutical Company, Experimental Station, PO Box 80400, Wilmington, Delaware, 19880-0400
Pages 1031-1035 | Published online: 20 Oct 2008

Citations (14)

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Read on this site (4)

Anil Menon & Makarand Jawadekar. (2003) Case Studies in Blend Sampling Using a Front-Loading Thief. Pharmaceutical Development and Technology 8:1, pages 61-70.
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Helena J. Venables & J. I. Wells. (2002) Powder Sampling. Drug Development and Industrial Pharmacy 28:2, pages 107-117.
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Jeannette Kræmer, Jørgen Ryhl Svensson & Henrik Melgaard. (1999) Sampling Bias in Blending Validation and a Different Approach to Homogeneity Assessment. Drug Development and Industrial Pharmacy 25:2, pages 217-222.
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Thomas P. Garcia, Michael K. Taylor & Girish S. Pande. (1998) Comparison of the Performance of Two Sample Thieves for the Determination of the Content Uniformity of a Powder Blend. Pharmaceutical Development and Technology 3:1, pages 7-12.
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Articles from other publishers (10)

Kim H. Esbensen, Andrés D. Román-Ospino, Adriluz Sanchez & Rodolfo J. Romañach. (2016) Adequacy and verifiability of pharmaceutical mixtures and dose units by variographic analysis (Theory of Sampling) – A call for a regulatory paradigm shift. International Journal of Pharmaceutics 499:1-2, pages 156-174.
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Janet Cho, Yunfeng Zhu, Karol Lewkowicz, SungHee Lee, Theodore Bergman & Bodhisattwa Chaudhuri. (2012) Solving granular segregation problems using a biaxial rotary mixer. Chemical Engineering and Processing: Process Intensification 57-58, pages 42-50.
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T.R.M. De Beer, C. Bodson, B. Dejaegher, B. Walczak, P. Vercruysse, A. Burggraeve, A. Lemos, L. Delattre, Y. Vander Heyden, J.P. Remon, C. Vervaet & W.R.G. Baeyens. (2008) Raman spectroscopy as a process analytical technology (PAT) tool for the in-line monitoring and understanding of a powder blending process. Journal of Pharmaceutical and Biomedical Analysis 48:3, pages 772-779.
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Hua Ma & Carl A. Anderson. (2008) Characterization of Pharmaceutical Powder Blends by NIR Chemical Imaging. Journal of Pharmaceutical Sciences 97:8, pages 3305-3320.
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Arwa S. El-Hagrasy, Frank D'Amico & James K. DrennenIIIIII. (2006) A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation. Journal of Pharmaceutical Sciences 95:2, pages 392-406.
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Arwa S. El-Hagrasy, Miriam Delgado-Lopez & James K. DrennenIIIIII. (2006) A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity. Journal of Pharmaceutical Sciences 95:2, pages 407-421.
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Arwa S. El-Hagrasy & James K. DrennenIIIIII. (2006) A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. Journal of Pharmaceutical Sciences 95:2, pages 422-434.
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Ting-Huei Lee & Shan-Yang Lin. (2004) Microspectroscopic FT-IR mapping system as a tool to assess blend homogeneity of drug?excipient mixtures. European Journal of Pharmaceutical Sciences 23:2, pages 117-122.
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G.J Vergote, T.R.M De Beer, C Vervaet, J.P Remon, W.R.G Baeyens, N Diericx & F Verpoort. (2004) In-line monitoring of a pharmaceutical blending process using FT-Raman spectroscopy. European Journal of Pharmaceutical Sciences 21:4, pages 479-485.
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Arwa S. El?Hagrasy, Hannah R. Morris, Frank D'Amico, Robert A. Lodder & James K. DrennenIIIIII. (2001) Near?infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. Journal of Pharmaceutical Sciences 90:9, pages 1298-1307.
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