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Items: 1 to 20 of 114

1.

Goals of stability evaluation throughout the vaccine life cycle.

Krause PR.

Biologicals. 2009 Nov;37(6):369-78; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.015. Epub 2009 Sep 22. Review.

PMID:
19775911
2.

Vaccine stability study design and analysis to support product licensure.

Schofield TL.

Biologicals. 2009 Nov;37(6):387-96; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.009. Epub 2009 Aug 29. Review.

PMID:
19717312
3.

Maintenance of vaccine stability through annual stability and comparability studies.

Schofield TL.

Biologicals. 2009 Nov;37(6):397-402; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.010. Epub 2009 Aug 31. Review.

PMID:
19717311
4.

Basic principles of stability.

Egan W, Schofield T.

Biologicals. 2009 Nov;37(6):379-86; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.012. Epub 2009 Aug 31.

PMID:
19720547
5.

Consideration on a few aspects of the stability studies post licensure.

Pierard I, Spelte G, Le Tallec D, Duchêne M.

Biologicals. 2009 Nov;37(6):403-6; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.011. Epub 2009 Oct 22. Review.

PMID:
19853472
6.

Stability post-licensure: compatibility container content - a practical case study.

Duchêne M, Jeanmart L, Slegers B.

Biologicals. 2009 Nov;37(6):407-9; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.006. Epub 2009 Aug 29.

PMID:
19717309
7.

Stability of vaccines - bridging from stability data to continuous safety and efficacy throughout shelf life - an always reliable approach?

Pfleiderer M.

Biologicals. 2009 Nov;37(6):364-8. doi: 10.1016/j.biologicals.2009.08.013. Epub 2009 Sep 20. Review.

PMID:
19773184
8.

Stability testing of vaccines: Developing Countries Vaccine Manufacturers' Network (DCVMN) perspective.

Jadhav SS, Dogar V, Gautam M, Gairola S.

Biologicals. 2009 Nov;37(6):360-3. doi: 10.1016/j.biologicals.2009.08.003. Epub 2009 Aug 29. Review.

PMID:
19717310
9.

Guidelines on stability evaluation of vaccines.

Dobbelaer R, Pfleiderer M, Haase M, Griffiths E, Knezevic I, Merkle A, Hongzhang Y, Candrian U, Castillo MA, Wood D, Daviaud J, Dellepiane N, Hernandez CA, Lambert S, Shin J-, Knezevic I, Daviaud J, Fournier-Caruna J, Kopp S, Zhou T, Zaffran M, Bektimirov TA, Cooper G, da Silveira SC, Egan W, Medveczky N, Morris T, Griffiths E, Nunez YH, Horiuchi Y, Jivapaisarnpong T, Krause P, Martin J, Southern J, Tyas Utami AR, Jadhav S, Susanti I, Yamaguchi IK, Duchene M, Laschi A, Schofield TL; World Health Organization.

Biologicals. 2009 Nov;37(6):424-34; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.017. Epub 2009 Oct 29. No abstract available.

PMID:
19875304
10.

WHO/KFDA workshop on stability evaluation of vaccines, Seoul, Korea, 23-25 April 2008.

Shin J, Smith D, Southern J, Knezevic I.

Biologicals. 2009 Nov;37(6):435-44; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.018. Epub 2009 Sep 23.

PMID:
19783459
11.

Stability evaluation of vaccines: WHO approach.

Knezevic I.

Biologicals. 2009 Nov;37(6):357-9; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.004. Epub 2009 Sep 3.

PMID:
19729320
12.

An annual vaccine: seasonal influenza.

Jivapaisarnpong T, Krause PR.

Biologicals. 2009 Nov;37(6):410-1; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.001. Epub 2009 Oct 21.

PMID:
19850497
13.

Robustness testing in pharmaceutical freeze-drying: inter-relation of process conditions and product quality attributes studied for a vaccine formulation.

Schneid SC, Stärtzel PM, Lettner P, Gieseler H.

Pharm Dev Technol. 2011 Nov-Dec;16(6):583-90. doi: 10.3109/10837450.2011.581287. Epub 2011 May 13.

PMID:
21563990
14.

Risk factors for improper vaccine storage and handling in private provider offices.

Bell KN, Hogue CJ, Manning C, Kendal AP.

Pediatrics. 2001 Jun;107(6):E100.

PMID:
11389298
15.

A vaccine measured with a highly variable assay: rabies.

Jivapaisarnpong T, Schofield T, Krause PR.

Biologicals. 2009 Nov;37(6):412-5; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.002. Epub 2009 Oct 20.

PMID:
19846319
16.
17.
18.

Pharmaceutical quality by design: product and process development, understanding, and control.

Yu LX.

Pharm Res. 2008 Apr;25(4):781-91. doi: 10.1007/s11095-007-9511-1. Epub 2008 Jan 10. Erratum in: Pharm Res. 2008 Oct;25(10):2463.

PMID:
18185986
20.

Monitoring the stability of human vaccines.

Fairweather WR, Mogg R, Bennett PS, Zhong J, Morrisey C, Schofield TL.

J Biopharm Stat. 2003 Aug;13(3):395-413.

PMID:
12921389

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