Page 34 - Assurance of Sterility for Sensitive Combination Products and Materials

22 Assurance of sterility for sensitive combination products and materials

[6] L.I. Linkow, J.R. Wagner, Management of implant-related problems and infections,
J. Oral Implantol. 19 (4) (1993) 321–335.
[7] Printzen, G., Relevance, pathogenicity and virulence of microorganisms in implant
related infections. Injury, 1996. 27 Suppl 3: p. SC9–15.
[8] D.G. Allison, A review: taking the sterile out of sterility, J. Appl. Microbiol. 87 (6)
(1999) 789–793.
[9] E. Regar, G. Sianos, P.W. Serruys, Stent development and local drug delivery, Br. Med.
Bull. 59 (2001) 227–248.
[10] B.J. Lambert, T.A. Mendelson, M.D. Craven, Radiation and ethylene oxide terminal
sterilization experiences with drug eluting stent products, AAPS PharmSciTech 12 (4)
(2011) 1116–1126.
[11] Y.V. Il’ichev, L. Alquier, Effects of E-BEAM sterilization on drug-eluting stents: Pacl-
itaxel degradation elucidated by LC-MS-MS with information-dependent acquisition,
J. Chromatogr. Sci. 49 (10) (2011) 807–817.
[12] J.H. Baron, R.K. Aggrawal, M. Azrin, Development of c7e3 fab (abciximab) eluting
stents for local drug delivery: effect of sterilization and storage, Circulation 98 (17)
(1998) 4487.
[13] A. Hagan, et al., Preparation and characterisation of vandetanib-eluting radiopaque
beads for locoregional treatment of hepatic malignancies, Eur. J. Pharm. Sci. 101 (2017)
22–30.
[14] D. Carugo, et al., Benefits of polidocanol endovenous microfoam (Varithena(R)) com-
pared with physician-compounded foams, Phlebology 31 (4) (2016) 283–295.
[15] R. Scherliess, et al., Induction of protective immunity against H1N1 influenza a(H1N1)
pdm09 with spray-dried and electron-beam sterilised vaccines in non-human primates,
Vaccine 32 (19) (2014) 2231–2240.
[16] B. McKay, Local sustained delivery of recombinant human bone morphogenetic
protein-2 (rhBMP-2), Conf. Proc. IEEE Eng. Med. Biol. Soc. 2009 (2009) 236–237.
[17] W. Friess, et al., Bone regeneration with recombinant human bone morphogenetic
protein-2 (rhBMP-2) using absorbable collagen sponges (ACS): Influence of processing
on ACS characteristics and formulation, Pharm. Dev. Technol. 4 (3) (1999) 387–396.
[18] A. Shmulewitz, R. Langer, The ascendance of combination products, Nat. Biotechnol.
24 (3) (2006) 277–280.
[19] D.R. Friend, et al., Multipurpose prevention technologies: products in development,
Antiviral Res. 100 (Suppl) (2013) S39–S47.