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AAPS PharmSciTech. 2003 June; 4(2): 109–118.
Published online 2003 April 29. doi:  10.1208/pt040224
PMCID: PMC2750586

Evaluation of the conformity index and the mahalanobis distance as a tool for process analysis: A technical note

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
1. Plugge W, Vlies C. Near-infrared spectroscopy as an alternative to assess compliance, of ampicillin trihydrate with compendial specifications. J Pharm Biomed Anal. 1993;11(6):435–442. doi: 10.1016/0731-7085(93)80154-S. [PubMed] [Cross Ref]
2. Mark HL, Tunnell D. Qualitative near infrared reflectance analysis using Mahalanobis distances. Anal Chem. 1985;57(7):1449–1456. doi: 10.1021/ac00284a061. [Cross Ref]
3. Burns DA, Ciurczak EW. Handbook of Near-Infrared Analysis. 2nd ed. New York, NY: Marcel Dekker; 1992. pp. 385–386.
4. Guideline for Industry: Text on Validation of Analytical Procedures. Rockville, MD: Food and Drug Administration; 1995.
5. Guidance for Industry: Validation of Analytical Procedures: Methodology. Rockville, MD: Food and Drug Administration; 1997.
6. US Pharmacopeia. <1225> Validation of Compendial Methods Vol 24 Rockville, MD: US Pharmacopeia; 1999:2149–2152.
7. <1119> Near Infrared Spectrophotometry. Pharmacopeial Forum. Nov–Dec 2002;28(6):1119.
8. <1119> Near Infrared Spectroscopy [New] (2nd Supp). Pharmacopeial Forum Sept–Oct 2002;27(5):1119.
9. Physical and Physicochemical Methods, Near Infrared Spectrometry. Strasbourg, France: European Pharmacopeia; 1997.
10. Broad N, Graham P, Hailey P, et al. Guidelines for the Development and Validation of Near Infrared Spectroscopic Methods in the Pharmaceutical Industry. In: Chalmers JH, Griffiths PR, et al., editors. Handbook of Vibrational Spectroscopy. Chichester, UK: John Wiley & Sons Ltd; 2002. pp. 1–22.
11. The European Agency for the Evaluation of Medicinal Products (EMEA). Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be Forwarded in Part II of the Dossier for a Marketing Authorization. EMEA; November 14, 2001:1–13. [PubMed]
12. Moffat AC, Trafford AD, Jee RD, Graham P. Meeting the International Conference on Harmonizationss Guidelines on Validation of Analytical Procedures: Quantification as Exemplified by a Near-Infrared Reflectance Assay of Paracetamol in Intact Tablets. Analyst. 2000;125:1341–1351. doi: 10.1039/b002672g. [PubMed] [Cross Ref]
13. Mark H, Ritchie GE, Roller RW, Ciurczak EW, Tso C, MacDonald SA. Validation of a Near-Infrared Transmission Spectroscopic Procedure, Part A: Validation Protocols. J Pharm Biomed Anal. 2002;28(2):251–260. doi: 10.1016/S0731-7085(01)00567-2. [PubMed] [Cross Ref]
14. Ritchie GE, Roller RW, Ciurczak EW, Mark H, Tso C, MacDonald SA. Validation of a Near-Infrared Transmission Spectroscopic Procedure, Part B: Application as an Alternate Content Uniformity and Release Assay Method for Pharmaceutical Solid Dosage Forms. J Pharm Biomed Anal. 2002;29(1–2):159–171. doi: 10.1016/S0731-7085(02)00010-9. [PubMed] [Cross Ref]
15. Whitfield RG, Gerger ME, Sharp RL. Near-Infrared Spectrum Qualification via Mahalanobis Distance Determination. Appl Spectrosc. 1987;41(7):1204–1213. doi: 10.1366/0003702874447572. [Cross Ref]
16. Burns D, Ciurczak E. Practical Spectroscopy Series. 2nd ed. New York, NY: Marcel Dekker; 2001. Handbook of Near-Infrared Analysis; pp. 363–393.
17. Kamat MS, Lodder RA, DeLuca PP. Near-Infrared Spectroscopic Determination of Residual Moisture in Lyophilized Sucrose Through Intact Glass Vials. Pharm Res. 1989;6(11):961–965. doi: 10.1023/A:1015997530367. [PubMed] [Cross Ref]
18. Lactose Monohydrate (USP Method) Rockville, MD: US Pharmacopeia; 2002. pp. 2570–2570.

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