The seamless phase II/III design combining phases II and III into a single trial has been shown growing interest for improving the efficiency of drug development, becoming most frequent adaptive type. It typically consists two stages, objectives being often different in each stage. primary are to select optimal experimental treatment group(s) first stage compare efficacy between selected contro...

PURPOSE Selecting an experimental arm for a Phase III trial is based on the results of Phase II investigations. Historical results show that this paradigm leads to the failure of many experimental therapies in the Phase III setting. This is the result of failures in the Phase II design that include differences in the patient populations and basing sample size determinations on levels of benefit...

Adsorption of Ce(III) from aqueous solution by amino phosphate modified nano TiO2 was investigated. Effects of pH of solution, adsorbent dose, contact time, initial metal concentration and temperature were examined. Experimental data were fitted well by the pseudo second order model. Adsorption was well described by Freundlich isotherm model with a maximum adsorption capacity of 25 mg g-1. Acco...

Given the multitude of novel anticancer drugs and the limited resources available to study them, phase II trials should identify drugs with the highest probability of succeeding in subsequent phase III trials. Currently, single-arm phase II trial results are interpreted relative to historical control subjects, introducing selection bias and confounding that may limit the validity of the conclus...

Lipegfilgrastim is a long-acting, once-per-cycle, glycopegylated recombinant granulocyte colony-stimulating factor (G-CSF) used to prevent neutropenia in patients receiving myelosuppressive chemotherapy. This integrated analysis examined the immunogenicity of lipegfilgrastim and its potential clinical impact in two double-blind randomized studies (phases II and III) of patients with breast canc...

The effect of local hydrogen concentration on nanoindentation-induced phase transformations has been investigated in ion-implanted amorphous silicon a-Si . Elevated concentrations of H ranging from 5 1018 to 5 1020 cm−3, over the depth of indentation-induced phase transformed zones have been formed in the a-Si by H ion-implantation. Indentation has been performed under conditions that result in...