Stab-e-lity - Bibliographic references

Bibliographic references

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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		Bibliographic references 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. Click here if you want to go back to the login page.
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