Dinical phase

An increasing number of companies include contract manufacturing into their plans for developing a bio-pharmaceutical drug (Table 16.2). Although, initially an appropriate quantity of material is required for toxicology studies (the pre-dinical phase), much larger quantities will be required further down the development chain as the clinical phase approaches (Fig. 16.3). 

The process of conducting dinical trials for drug approval may be broken down into three consecutive phases of ... 

Methodologies for scale-out to phase II-III dinical trials are also given in Figure 9.12 [44]. One approach would be to scale up the c-SSP using static mixers and mini-heat exchangers, which are already in operation at Lonza. The possible... 

Algotar AM, Stratton MS, Ahmann FR, Ranger-Moore J, Nagle RB, Thompson PA, et al. Phase 3 dinical trial investigating the effect of selenium supplementation in men at high-risk for prostate cancer. Prostate 2013 73(3) 328-35. 

Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, et al. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1 results of a phase 2, randomized, controlled, dose-ranging dinical trial. J Infect Dis 2010 201(6) 814-22. 

Pardo, B., Paz-Ares, L, Tabernero, J., Ciruelos, E., Garcia, M., Salazar, R., Lopez, A., Blanco, M., Nieto, A., Jimeno, J., Izquierdo, M.A., and Trigo, J.M. (2008) Phase 1 dinical and pharmacokinetic study of kahalalide F administered weekly as a 1-hoiu infusion to patients with advanced soUd tumors. Clin, Cancer Res, 14,1116-1123. 

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