Erythropoietin case study

In this case study a simulation strategy, based on a mechanistic PK/PD model, was developed to predict the outcome of the first time in man (FTIM) and proof of concept (POC) study of a new erythropoietin receptor agonist (ERA). A description of the erythropoiesis model, along with the procedures to scale the pharmacokinetics and pharmacodynamics based on preclinical in vivo and in vitro information is presented. The Phase I study design is described and finally the model-based predictions are shown and discussed. 

Hermeling S, Jiskoot W, Crommelin DJA, et al. Reaction to the paper interaction of polysorbate with erythropoietin a case study in protein-surfactant interactions. Pharm Res 2006 23(3) 641-642. 

Several pure proteins have been purified and checked for their purity, microheterogeneity, or diagnostic significance by CE. In this case, coated capillaries are preferred for this separation. Many of the proteins can be analyzed by CE however, sensitive detectors such as fluorescence are necessary [68-70]. Examples of proteins studied by CE separately or in a profile are transferrin isoforms, which are important as markers of alcoholism [71], a-1 antitrypsin [72], recombinant human erythropoietin glycoforms that stimulates erythopiosis [73], plasminogen tissue activator [74], prions [75], urothelial carcinoma proteins in urine [76,77], and numerous urinary proteins [78]. 

Haematological There have been further descriptions, in case reports and studies [82, 83 84 85 -], of anaemia managed with erythropoietin, blood transfusion or discontinuation of treatment. 

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