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Drug Development and Industrial Pharmacy Volume 29, 2003 - Issue 5
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Research Article

Comparison of Shelf-Life Estimates for a Human Insulin Pharmaceutical Preparation Using the Matrix and Full-Testing Approaches

Alexis Oliva Departamento Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, La Laguna, Tenerife, Spain
,
José Fariña Departamento Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, La Laguna, Tenerife, Spain
&
Matías Llabrés Departamento Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, La Laguna, Tenerife, Spain
Pages 513-521 | Published online: 05 Dec 2003

References

  • The Stability Testing of New Drug Substances and Products—The Tripartite Guideline. US Pharmacopeia XXIII. US Pharmacopeial Convention, Rockville, MD 1995; pp. 1959–1963
  • Golden M.H., Cooper D.C., Riebe M.T., Carswell K.E. A matrixed approach to long-term stability testing of pharmaceutical products. J. Pharm. Sci. 1996; 85: 240–245
  • Ruberg S.J., Stegeman J.W. Pooling data for stability studies: testing the equality of batch degradation slopes. Biometrics 1991; 47: 1059–1069
  • Bancroft T.A. Analysis and inference for incompletely specified models involving the use of preliminary test of significance. Biometrics 1964; 20: 427–442
  • Norwood T.E. Statistical analysis of pharmaceutical stability data. Drug. Dev. Ind. Pharm. 1986; 12: 553–560
  • Langenbucher F. Statistical analysis of stability data by means of general linear models (GLM). Drug. Dev. Ind. Pharm. 1991; 17: 165–181
  • Chow S.C., Shao J. Estimating drug shelf-life with random batches. Biometrics 1991; 47: 1071–1079
  • Llabrés M., Oliva A., Fariña J. Statistical assessment of between batch stability equivalence. Int J. Pharm. 2000; 204: 61–68
  • Farid N.A., Atkins L.M., Becker G.W., Dinner A., Heiney R.E., Miner D.J., Riggin R.M. Liquid chromatographic control of the identity, purity and potency of biomolecules used as drugs. J. Pharm. Biomed. Anal. 1989; 7: 185–188
  • Hunter W.G., Lamboy W.F. A Bayesian analysis of the linear calibration problem. Technometrics 1981; 23: 323–328
  • Oliva A., Fariña J., Llabrés M. Development of two high-performance liquid chromatographic methods for the analysis and characterization of insulin and its degradation products in pharmaceutical preparations. J. Chromatogr. B 2000; 749: 25–34
  • Haynes J.D. Worldwide virtual temperature for product stability testing. J. Pharm. Sci. 1971; 60: 927–929
  • Oliva A., Fariña J., Llabrés M. Influence of temperature and shaking on stability of insulin preparations: Degradation kinetics. Int. J. Pharm. 1996; 143: 163–170
  • Wolfram S. Mathematica: A System for Doing Mathematics by Computer. Wolfram Research, Inc. & Addison-Wesley Publishing Company, Inc. 1988

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