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Chapter 22: Assuring the quality, safety and efficacy of HPV vaccines: the scientific basis of regulatory expectations pre- and post-licensure.
Wood D, Shin JH, Duval B, Schmitt HJ. Wood D, et al. Among authors: shin jh. Vaccine. 2006 Aug 31;24 Suppl 3:S3/187-92. doi: 10.1016/j.vaccine.2006.05.095. Epub 2006 Jun 12. Vaccine. 2006. PMID: 16950006 Review.
Validation of a computer software program for statistical analysis of accelerated stability studies on biological standards.
Shin J, Nam J. Shin J, et al. Biologicals. 2007 Mar;35(1):27-30. doi: 10.1016/j.biologicals.2006.01.001. Epub 2006 Mar 31. Biologicals. 2007. PMID: 16580228
WHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24-25 January 2005.
van der Laan JW, Minor P, Mahoney R, Arntzen C, Shin J, Wood D; WHO Informal Consultation Group. van der Laan JW, et al. Vaccine. 2006 May 15;24(20):4271-8. doi: 10.1016/j.vaccine.2005.12.063. Vaccine. 2006. PMID: 16767805
WHO informal consultation on the application of molecular methods to assure the quality, safety and efficacy of vaccines, Geneva, Switzerland, 7-8 April 2005.
Shin J, Wood D, Robertson J, Minor P, Peden K; WHO Informal Consultation Group. Shin J, et al. Biologicals. 2007 Mar;35(1):63-71. doi: 10.1016/j.biologicals.2005.12.005. Epub 2006 Feb 20. Biologicals. 2007. PMID: 17321940
WHO informal consultation on the scientific basis of specifications for production and control of inactivated Japanese encephalitis vaccines for human use, Geneva, Switzerland, 1-2 June 2006.
Ferguson M, Kurane I, Wimalaratne O, Shin J, Wood D; WHO informal consultation group. Ferguson M, et al. Vaccine. 2007 Jul 20;25(29):5233-43. doi: 10.1016/j.vaccine.2007.05.034. Epub 2007 Jun 8. Vaccine. 2007. PMID: 17590244
Model format for a vaccine stability report and software solutions.
Shin J, Southern J, Schofield T. Shin J, et al. Biologicals. 2009 Nov;37(6):417-20; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.007. Epub 2009 Aug 31. Biologicals. 2009. PMID: 19720545 Review.
WHO/KFDA workshop on stability evaluation of vaccines, Seoul, Korea, 23-25 April 2008.
Shin J, Smith D, Southern J, Knezevic I. Shin J, et al. Biologicals. 2009 Nov;37(6):435-44; discussion 421-3. doi: 10.1016/j.biologicals.2009.08.018. Epub 2009 Sep 23. Biologicals. 2009. PMID: 19783459
WHO Working Group on technical specifications for manufacture and evaluation of dengue vaccines, Geneva, Switzerland, 11-12 May 2009.
Trent D, Shin J, Hombach J, Knezevic I, Minor P; WHO Working Group. Trent D, et al. Vaccine. 2010 Dec 6;28(52):8246-55. doi: 10.1016/j.vaccine.2010.10.043. Epub 2010 Oct 29. Vaccine. 2010. PMID: 21036129
WHO Working Group on Technical Specifications for Manufacture and Evaluation of Yellow Fever Vaccines, Geneva, Switzerland, 13-14 May 2009.
Ferguson M, Shin J, Knezevic I, Minor P, Barrett A; WHO Working Group. Ferguson M, et al. Vaccine. 2010 Dec 6;28(52):8236-45. doi: 10.1016/j.vaccine.2010.10.070. Epub 2010 Nov 4. Vaccine. 2010. PMID: 21055492 Free PMC article.
WHO working group on the quality, safety and efficacy of japanese encephalitis vaccines (live attenuated) for human use, Bangkok, Thailand, 21-23 February 2012.
Trent DW, Minor P, Jivapaisarnpong T, Shin J; WHO Working Group on the Quality, Safety and Efficacy of Japanese Encephalitis Vaccines Live Attenuated for Human Use. Trent DW, et al. Biologicals. 2013 Nov;41(6):450-7. doi: 10.1016/j.biologicals.2013.06.001. Epub 2013 Jul 25. Biologicals. 2013. PMID: 23891495
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