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Bibliographic references for shelf-life computation:
- Allen PV, Dukes GR, Gerger ME. Determination of release limits: a general methodology. Pharmaceutical Research. 1991;8(9):1210-1213.
- Apostol I, Schofield T, Koeller G, Powers S, Stawicki M, Wolfe RA. A rational approach for setting and maintaining specifications for biological and biotechnology-derived products. BioPharm International. 2008.
- Chow SC. Statistical Design and Analysis of Stability Studies. Chapman & Hall; 2007.
- Fuller WA, Battese GE. Transformations for estimation of linear models with nested-error structure. Journal of american statistical association. 1973;68(343):626-632.
- Huynh-Ba K. Handbook of stability testing in pharmaceutical development. Springer;2009.
- Komka K, Kemeny S. A modified error model for the assessment of stability of pharmaceutical products. Chemometrics and Intelligent Laboratory Systems. 2004;72:161-165.
- Lee KR, Gagnon RC. Calibration and stability analysis with a simple mixed linear model when the experiment is of a split-plot type. Drug Development and Industrial Pharmacy. 1996;22(2):143-151.
- Murphy JR, Hofer JD. Establishing shelf-life, expiry limits and release limits. Drug Information Journal. 2002;36:769-781.
- Neter J, Wasserman W, Kunter MH. Applied Linear Statistical Models, 3rd ed., Irwin:1990.
- Pinheiro JC, Bates DM. Mixed-effects models in S and S-Plus. Springer-Verlag; 2000.
- SAS Institute Inc. SAS/STAT 9.2 User's Guide. Cary, NC: SAS Institute Inc; 2008.
- Schabenberger O. Mixed model influence diagnostics. SUGI 29 Proceedings. Paper 189-29. SAS Institute Inc.
- Schofield TL. Vaccine stability study design and analysis to support licensure. Biologicals. 2009;37:387-396.
- Guidance for Industry : Guideline for Submitting Documentation For The Stability of Human Drugs and Biologics, Food and Drug Administration, Center For Drugs and Biologics, Office of Drug Research and Review. 1987.
- International Conference on Harmonization (ICH) Topic Q1A(R2) Stability Testing of New Drug Substances and Products. 2003. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1B Stability Testing : Photostability Testing of New Drug Substances and Products. 1996. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-photostability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1C Stability Testing of New Dosage Forms. 1996. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-for-new-dosage-forms.html.
- International Conference on Harmonization (ICH) Topic Q1E Evaluation of Stability Data. 2003. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html.
- International Conference on Harmonization (ICH) Topic Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. 1999. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-new-drug-substances-and-new-drug-produc.html.
- International Conference on Harmonization (ICH) Topic Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. 1999. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products.html.
- International Conference on Harmonization (ICH) Topic Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products. 1995. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-biotechnologicalbiological-products.html.
- International Conference on Harmonization (ICH) Topic Q5E Comparability of Biotechnological/Biological products Subject to Changes in Their Manufacturing Process. 2004. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html.
- International Conference on Harmonization (ICH) M4Q(R1) CTD Quality. 2002. Available from: http://www.ich.org/products/ctd/ctdsingle/article/m4qr1-quality.html.
- World Health Organization (WHO) Draft Guidelines on Stability Evaluation of Vaccines. 2006.
- World Health Organization (WHO) Workshop on Stability Evaluation of Vaccines, Seoul Republic of Korea. Meeting Report. 2008.
Bibliographic references for accelerated testing:
- Allen PV, Dukes GR, Gerger ME. Determination of release limits: a general methodology. Pharmaceutical Research. 1991;8(9):1210-1213.
- Apostol I, Schofield T, Koeller G, Powers S, Stawicki M, Wolfe RA. A rational approach for setting and maintaining specifications for biological and biotechnology-derived products. BioPharm International. 2008.
- Baertschi SW. Pharmaceutical Stress testing-Predicting Drug Degradation, Taylor & Francis Group: 2005.
- Chow SC. Statistical Design and Analysis of Stability Studies. Chapman & Hall; 2007.
- Egan W, Schofield T. Basic principles of stability. Biologicals. 2009;37:379-386.
- Fuller WA, Battese GE. Transformations for estimation of linear models with nested-error structure. Journal of american statistical association. 1973;68(343):626-632.
- Golden MH, Cooper DC, Riebe MT, Carswell KE. A Matrixed Approach to Long-Term Stability Testing of Pharmaceutical products. 1996;85(2):240-245.
- Huynh-Ba K. Handbook of stability testing in pharmaceutical development. Springer;2009.
- Komka K, Kemeny S. A modified error model for the assessment of stability of pharmaceutical products. Chemometrics and Intelligent Laboratory Systems. 2004;72:161-165.
- Lee KR, Gagnon RC. Calibration and stability analysis with a simple mixed linear model when the experiment is of a split-plot type. Drug Development and Industrial Pharmacy. 1996;22(2):143-151.
- Lin TYD, Chen CW. Overview of Stability Study Designs. Journal of Biopharmaceutical Statistics. 2003;13(3):337-354.
- Magari RT. Assessing Shelf-Life Using Real-Time and Accelerated Stability Tests. BioPharm International. 2003.
- Magari RT, Murphy KP, Fernandez T. Accelerated Stability Model for Predicting Shelf-Life. Journal of Clinical Laboratory Analysis. 2002;16:221-226.
- Murphy JR, Hofer JD. Establishing shelf-life, expiry limits and release limits. Drug Information Journal. 2002;36:769-781.
- Neter J, Wasserman W., Kunter MH. Applied Linear Statistical Models, 3rd ed., Irwin:1990.
- Pierard I, Spelte G, Le Tallec D, Duchêne M. Consideration on a few aspects of the stability studies post licensure. Biologicals. 2009;37:403-406.
- Pinheiro JC, Bates DM. Mixed-effects models in S and S-Plus. Springer-Verlag;2000.
- SAS Institute Inc. SAS/STAT 9.2 User's Guide. Cary, NC: SAS Institute Inc;2008.
- Schabenberger O. Mixed model influence diagnostics. SUGI 29 Proceedings. Paper 189-29. SAS Institute Inc.
- Schofield TL. Vaccine stability study design and analysis to support licensure. Biologicals. 2009;37:387-396.
- Guidance for Industry : Guideline for Submitting Documentation For The Stability of Human Drugs and Biologics, Food and Drug Administration, Center For Drugs and Biologics, Office of Drug Research and Review. 1987.
- International Conference on Harmonization (ICH) Topic Q1A(R2) Stability Testing of New Drug Substances and Products. 2003. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1B Stability Testing : Photostability Testing of New Drug Substances and Products. 1996. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-photostability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1C Stability Testing for New Dosage Forms. 1996. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-for-new-dosage-forms.html.
- International Conference on Harmonization (ICH) Topic Q1D Bracketing and Matrixing designs for Stability Testing of Drug Substances and Drug Products. 2002. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/bracketing-and-matrixing-designs-for-stability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1E Evaluation of Stability Data. 2003. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html.
- International Conference on Harmonization (ICH) Topic Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances. 1999. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-new-drug-substances-and-new-drug-produc.html.
- International Conference on Harmonization (ICH) Topic Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. 1999. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products.html.
- International Conference on Harmonization (ICH) Topic Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products. 1995. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-biotechnologicalbiological-products.html.
- International Conference on Harmonization (ICH) Topic Q5E Comparability of Biotechnological/Biological products Subject to Changes in Their Manufacturing Process. 2004. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html.
- International Conference on Harmonization (ICH) M4Q(R1) CTD Quality. 2002. Available from: http://www.ich.org/products/ctd/ctdsingle/article/m4qr1-quality.html.
- World Health Organization (WHO) Draft Guidelines on Stability Evaluation of Vaccines. 2006.
- World Health Organization (WHO) Workshop on Stability Evaluation of Vaccines, Seoul, Republic of Korea. Meeting Report. 2008.
Bibliographic references for commercial stability:
- Guidance for Industry : Guideline for Submitting Documentation For The Stability of Human Drugs and Biologics, Food and Drug Administration, Center For Drugs and Biologics, Office of Drug Research and Review. 1987.
- International Conference on Harmonization (ICH) Topic Q1A(R2) Stability Testing of New Drug Substances and Products. 2003. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1B Stability Testing : Photostability Testing of New Drug Substances and Products. 1996. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-photostability-testing-of-new-drug-substances-and-products.html.
- International Conference on Harmonization (ICH) Topic Q1C Stability Testing of New Dosage Forms. 1996. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-for-new-dosage-forms.html.
- International Conference on Harmonization (ICH) Topic Q1E Evaluation of Stability Data. 2003. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html.
- International Conference on Harmonization (ICH) Topic Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances. 1999. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-new-drug-substances-and-new-drug-produc.html.
- International Conference on Harmonization (ICH) Topic Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. 1999. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products.html.
- International Conference on Harmonization (ICH) Topic Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products. 1995. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-biotechnologicalbiological-products.html.
- International Conference on Harmonization (ICH) Topic Q5E Comparability of Biotechnological/Biological products Subject to Changes in Their Manufacturing Process. 2004. Available from: http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html.
- International Conference on Harmonization (ICH) M4Q(R1) CTD Quality. 2002. Available from: http://www.ich.org/products/ctd/ctdsingle/article/m4qr1-quality.html.
- World Health Organization (WHO) Draft Guidelines on Stability Evaluation of Vaccines. 2006.
- World Health Organization (WHO) Workshop on Stability Evaluation of Vaccines, Seoul, Republic of Korea. Meeting Report. 2008.
- Pharmaceutical Research and Manufacturers of America, RMA CMC Statistics and Stability Expert Teams, "Identification of Out-of-Trend Stability results", Pharmaceutical Technology 27(4), 38-52 (2003).
- Pharmaceutical Research and Manufacturers of America, RMA CMC Statistics and Stability Expert Teams, "Identification of Out-of-Trend Stability results, Part II", Pharmaceutical Technology 29(10), 66-78 (2005).
- Guidance for Industry : Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, Food and Drug Administration, Center for Drug Evaluation and Research, 2006.
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