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In DSC analysis, 22.46 % weight loss was observed during phase I of degradation at 60 120 °C and 67.23 % at ≥287 °C due to evaporation of water during the heating process, while the phase II stage of degradation was attributable to thermal decomposition as another study (Parikh and Madamwar 2006).
Although end-points based on RECIST criteria can and should be utilised in randomised phase II trials, we do not believe that revision of the RECIST criteria will result in a fundamental improvement in drug development decisions in the absence of randomised clinical trials at the phase II stage of drug development.
Phase II stage.
The initial Phase II stage, with response as the primary outcome measure, randomises 50 patients to each of four arms: TC, IT, GD and IFOS.
A constant recruitment rate of 200 patients/year was assumed for the intermediate (phase II) stage and a much higher recruitment rate of 800 patients/year was used for the second (phase III) stage.
Interestingly, two separate companies are working on different miR-122 inhibitors, with Santaris Pharma currently at Phase II stage and Regulus Therapeutics at Phase I stage of clinical trial [ 89].
Similar(48)
Novel paths have also been struck with radiochemotherapeutic approaches where various platin-containing regimen have been tested over the years but have not evolved beyond the phase II-stage or retrospective analyses [ 13- 16].
Radiochemotherapy in treatment of malignant salivary gland tumors however, has not evolved beyond the phase II-stage or retrospective analysis of very heterogeneous treatment regimen [ 22- 24] into a treatment standard so far.
The initial phase of exponential berry growth (stage I) is followed by a lag phase (stage II), with growth resuming after the onset of ripening or "veraison" (stage III).
During the hydrolysis phase (Stage I), bio-polymers are degraded into monomers or oligomers which are fermented into volatile organic acids, alcohols, CO2, and H2 in the acidogenesis phase (Stage II).
Both total correct entries and number of errors during the acquisition (Stage I) and rotation (Stage II) phases were analyzed.
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