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Items: 1 to 20 of 97

1.

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
2.

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
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.

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

Pierard I, Spelte G, Le Tallec D, DuchĂȘne 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
5.

Stability evaluation of vaccines.

Schofield T, Krause PR.

Biologicals. 2009 Nov;37(6):355. doi: 10.1016/j.biologicals.2009.09.001. Epub 2009 Sep 26. No abstract available.

PMID:
19783158
6.

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
7.

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

DuchĂȘne 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
8.

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
9.

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
10.

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
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.

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
13.

Combined vaccines - case study.

Jivapisarnpong T.

Biologicals. 2009 Nov;37(6):416; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.008. Epub 2009 Sep 15.

PMID:
19758822
14.

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
15.
16.

EORTC/CRC/NCI guidelines for the formulation of investigational cytotoxic drugs.

Davignon JP, Slack JA, Beijnen JH, Vezin WR, Schoemaker TJ.

Eur J Cancer Clin Oncol. 1988 Sep;24(9):1535-8. No abstract available.

PMID:
3181274
17.

International Conference on Harmonisation; evaluation of stability data; availability. Notice.

Food and Drug Administration, HHS.

Fed Regist. 2004 Jun 8;69(110):32010-1.

18.

Assessment of drug metabolites.

Izumi T.

Drug Metab Pharmacokinet. 2011;26(2):121-2. No abstract available.

19.

A consideration of the guidelines for investigating potential new drugs in humans in the United Kingdom.

McGillion FB.

Methods Find Exp Clin Pharmacol. 1979 Apr;1(1):45-50. No abstract available.

PMID:
552581
20.

Comments on 'Sample size for equivalence trials: A case study from a vaccine lot consistency trial' by J. Ganju, A. Izu and A. Anemona, Statistics in Medicine 2008; 27:3743-3754.

Kohberger RC.

Stat Med. 2009 Jan 15;28(1):177-8, author reply 178-9. doi: 10.1002/sim.3443. No abstract available.

PMID:
18937271
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