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Pharmaceutical Development and Technology Volume 18, 2013 - Issue 6
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Research Article

Content uniformity testing: suitability of different approaches for marketed low dose tablets

Magdi M. Abdel HamidDr WalidKayyali Chair for Pharmaceutical Industries, Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaCorrespondence[email protected]
,
Mohamed A. ElnabrawiDepartment of Pharmaceutics, College of Pharmacy, Cairo University, Cairo, Egypt
,
Fars K. AlanaziDr WalidKayyali Chair for Pharmaceutical Industries, Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
,
Magdy I. MohamedDepartment of Pharmaceutics, College of Pharmacy, Cairo University, Cairo, Egypt
&
Adel A. SakrDr WalidKayyali Chair for Pharmaceutical Industries, Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
Pages 1277-1287 | Received 11 Jun 2011, Accepted 21 Dec 2011, Published online: 13 Feb 2012

References

  • Zheng JY. An overview. Formulation and analytical development for low-dose oral drug products. Hoboken, New Jersey: John Wiley & Sons, Inc.; 2009. p. 10–20.
  • Short SM, Cogdill RP, D’Amico F, Drennen JK 3rd, Anderson CA. A new definition of pharmaceutical quality: assembly of a risk simulation platform to investigate the impact of manufacturing/product variability on clinical performance. J Pharm Sci 2010;99:5046–5059.
  • French WN, Matsui F, Cook D, Levi L. Pharmacopeial standards and specifications for bulk drugs and solid oral dosage forms. Similarities and differences. J Pharm Sci 1967;56:1622–1641.
  • NFXII. National Formulary 12. Easton: Mack Publishing Co.; 1965. p. 799.
  • USPXVII. United States Pharmacopoeia 17. Easton: Mack Publishing Co.; 1965. p. 905.
  • Chapter<905>_USP34NF29. Uniformity of Dosage Units. United States Pharmacopoeia 34 National Formulary 29. Rockville, MD2011.
  • Chapter<905>_USP23NF18. Uniformity of Dosage Units United States Pharmacopoeia 23 National Formulary 18. Rockville, MD1995.
  • BP. Tablets. British Pharmacopoeia. London: Her Majesty’s Stationery Office; 1980. p. 727–830.
  • USPXXINFXVI. Uniformity of Dosage Units <905>.United States Pharmacopoeia 21 National Formulary 16. Rockville, MD1985.
  • Chapter<905>_USP30NF25. Uniformity of Dosage Units. United States Pharmacopoeia 30 National Formulary 25. Rockville, MD2007.
  • Short SM, Cogdill RP, Drennen Iii JK, Anderson CA. Performance-based quality specifications: The relationship between process critical control parameters, critical quality attributes, and clinical performance. J Pharmaceut Sci 2011;100:1566–1575.
  • Utter M, Bergum J. Statistical Methods for Uniformity and Dissolution Testing. Pharmaceutical Process Validation: Informa Healthcare; 2003.
  • USP. General Announcements, USP–NF General Chapter <905> Uniformity of Dosage Units. [cited 2011 20 March]; Available from: http://www.usp.org/USPNF/notices/generalChapter905.html.
  • Bánfai B, Ganzler K, Kemény S. Content uniformity and assay requirements in current regulations. J Chromatogr A 2007;1156:206–212.
  • Sandell D, Vukovinsky K, Diener M, Hofor J, Pazdan J, Timmermans J. Development of a content uniformity test suitable for large sample sizes. Horsham, PA, Etats-Unis: Drug Information Association; 2006.
  • DienerM, LarnerG, Pazdan J, Pfahler L, Strickland H, Vukovinsky K, Andersen S. Development of a Content Uniformity Test Suitable for Sample Sizes Between 30 and 100. Horsham, PA, Etats-Unis Drug Information Association; 2009.
  • PDR. Physician’s Desk Reference. New Jersey: Thomson; 2006.
  • de Leon J, Sandson NB, Cozza KL. A preliminary attempt to personalize risperidone dosing using drug-drug interactions and genetics: part I. Psychosomatics 2008;49:258–270.
  • Kinon BJ, Ahl J, Stauffer VL, Hill AL, Buckley PF. Dose response and atypical antipsychotics in schizophrenia. CNS Drugs 2004;18:597–616.
  • Kapur S, Remington G. Serotonin-dopamine interaction and its relevance to schizophrenia. Am J Psychiatry 1996;153:466–476.
  • Nováková L, Matysová L, Solich P. Advantages of application of UPLC in pharmaceutical analysis. Talanta 2006;68:908–918.
  • ICH_Q2A. Text on Validation of analytical methods: definition and terminology. 1995.
  • Chapter<1225>_USP34NF29. Validation of compendial procedures. United States Pharmacopoeia 34 National Formulary 29. Rockville, MD2011.
  • Pietra V, Setnikar I. Testing for uniformity: sampling plans in pharmacopeias for weight, volume, and content uniformity. J Pharm Sci 1970;59:530–535.
  • Lunney P, Anderson C. Investigation of the statistical power of the content uniformity tests using simulation studies. J Pharmaceut Innov 2009;4:24–35.

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