Ex vivo evaluations

Regulatory guidance for non-clinical cardiovascular safety pharmacology testing is given in the ICH S7A and B.25,42 The effects of an NCE on blood pressure, heart rate, and the ECG should be evaluated. Furthermore, in vivo, in vitro, and ex vivo evaluations, including methods for (assessing) repolarization and conductance abnormalities, should... 

The ICH guideline lists the assessment of effects on blood pressure, heart rate and ECG. In vivo, in vitro and/or ex vivo evaluations, including methods for electrical repolarisation and conductance abnormalities, should also be considered. These abnormalities can be associated with risks for fatal ventricular arrhythmias called Torsade de pointes. 

Figure 10. Ex vivo evaluation of blood compatibility of urethanation with 100% HMDI. Key O, glass , virgin EVAL A, EVAL urethanated for 3 h with 100% HMDI grafted with dextran for 1 h.

Genta, I., Perugini, P., Pavanetto, F., Maculotti, K., Modena, T., Casado, B., Lupi, A., Iadarola, R, and Conti, B. (2001), Enzyme loaded biodegradable microspheres in vitro ex vivo evaluation, J. Controlled Release, 77,287-295. 

De TK, Bergey EJ, Chung JS, et al. Polycarboxylic acid nanoparticles for ophthalmic drug delivery an ex vivo evaluation with human cornea. J Microencapsul 2004 21 841-855. 

Hahnen E, Eyupoglu IY, Brichta L et al (2006) In Vitro and ex vivo evaluation of second-generation histone deacetylase inhibitors for the treatment of spinal muscular atrophy. J Neurochem 98 193-202... 

Hayashi, K., Hayashi, T., and Kojima, I. (1996a). A natural sulfated polysaccharide, calcium spirulan, isolated from Spirulina platensis In vitro and ex vivo evaluation of anti-Herpes simplex virus and anti-human immunodeficiency virus activities. AIDS Res. Hum. Retroviruses 12,1463-1471. 

Anti-Inflammatory Phytochemicals in Vitro and Ex Vivo Evaluation... 

Giuliano, E, Ferraz J.G., Pereira R, de Nucci G., and Warner T.D., Cyclooxygenase selectivity of non-steroid anti-inflammatory drugs in humans ex vivo evaluation, Eur J Pharmacol, 2001 426(l-2) 95-103. 

Genta, I. et al., Enzyme loaded biodegradable microspheres in vitro ex vivo evaluation, J. Control. Rel., 77, 287, 2001. 

Saretni, S., Atyabi, R, Akhlaghi, S. R, Ostad, S. N., and Dinarvand, R. (2011). Thiolated chitosan nanoparticles for enhancing oral absorption of docetaxel Preparation, in vitro and ex vivo evaluation of penetration enhancement properties, hit J. Nanomed., 6,119-128. 

P. Jain, V. Pruthi, V.K. Sikri, An ex vivo evaluation of the sealing ability of polydimethylsUoxane-based root canal sealers, Indian J. Dent. Res. 25 (2014) 336-339. 

Gupta, S., Chavhan, S., Sawant, K.K., 2011. Self-nanoemulsifying drug debvery system for adefovir dipivoxil design, characterization, in vitro and ex vivo evaluation. Colloids Surf. A Physicochem. Eng. Aspects 392, 145—155. 

Fig. 26. Ex vivo evaluation of the blood compatibility of various surfaces. O glass siliconized glass poly(vinyl alcohol) A vinyl alcohol-ethylene copolymer A polyethylene...

Ex vivo evaluation by kinetic methods has revealed that the coupling grafting with dextran onto VAECO films improves the blood compatibility to some extent... 

Fig. Z7. Ex vivo evaluation of the Hood compattUfity of poly(vinyl alcohol) annealed in N2 at differoit temperatures. 60 °C 150 °C A 170 °C A210 °C O gte r -—...

HAL 12] Haller C.M., Buerzle W., Kivelio A. et al, Mussel-mimetic tissue adhesive for fetal membrane repair An ex vivo evaluation , Acta Biomaterialia, vol. 8,pp. 4365-4370, 2012. 

Singh, J., Chhabra, G., Pathak, K. Development of acetazolamide-loaded, pH-triggered polymeric nanoparticulate in situ gel for sustmned ocular delivery in vitro, ex vivo evaluation and pharmacodynamic study. Drug Dev. Ind. Pharm. 40(9), 1223-1232 (2014)... 

Sharma, R, Rawal, R. K., Gaba, T, Singla, N., Malhotra, M., Matharoo, S., Bhardwaj, T. R. (2013). Design, synthesis and ex vivo evaluation of colon-specific azo based prodrugs of anticancer agents, Bioorg. Med. Chem. Lett., 23,5332-5338. 

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