Protein drugs definition

By current definition, proteome means simply the internal protein-world of the organism while genome represents its internal DNA world. This definition invokes the all-important issue of three-dimensional structures of proteins, which are in turn the basis of the rational design of drugs. It also invokes many other aspects of protein function, such as protein-protein and protein-drug interactions. Within such broad definition, many companies are now active in areas that can reasonably be described as proteomics. 

Since the number of recombinant protein drugs will substantially increase over the next decade, analytical as well as bioan-alytical methods for the characterization of such macromolecules will definitively gain in importance. Especially the vaKdation of bioanalytical methods is of key importance to allow an accurate description of protein drugs. This requires harmonized guidelines, which are not yet existing but seem to be on the way, to accelerate drug development. 

Biology Structuie of biomolecules, design of drugs, enzymes and other active species, immunological responses, peptide studies, protein study, definition of DMA and RNA... 

Figure 4 Representation of protein-bound and unbound drug in a noneliminating membrane-limited organ structure. See text for definition of symbols. 

Another term that is used for protein-based drugs is biologies. The FDA gives the following definition for biologies ... 

The result of the Phase II trial is information needed to determine the effective dose and the dosing regimen of frequency and duration. Specihc chnical endpoints or markers are used to assess interaction of drug and disease. There are two types of markers definitive and surrogate. For example, in the case of cancer or hypertension, the definitive markers are mortality and stroke, respectively, and the surrogate markers may be tumor size, or cancer-associated proteins p53, TGF-a in the case of cancer, and blood pressure or cholesterol level in hypertension. Statistical analysis is carried out to evaluate the... 

Although a number of assays and technologies are available to characterize and test protein molecules, such as peptide mapping, protein sequencing, carbohydrate analysis, electrophoresis, ELISA, and mass spectroscopy, they are not as definitive as the methods used for small molecule drugs. Hence, the test for similarity is not as well defined in the case of proteins. However, as... 

Siegel, N., Stadler, J., Tilbury, L. and Smith, D. (2007) PEGylated proteins evaluation of their safety in the absence of definitive metabolism studies. Drug Metab. Dispos., 35 (1), 9-16. 

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