DESI drug

E. DESI (Drug Efficacy Study Implementation Program)... 

FDA becomes part of the Public Health Service (PHS). The Drug Efficacy Study Implementation (DESI) is FDA s response to the investigation on the effectiveness of drugs. 

The FDA pace of implementation of the 1962 Amendments was, however, necessarily slow. The American Public Health Association therefore brought a lawsuit to require FDA to complete its DESI programme for pre-1962 new drugs. 

Hermann, T. (2000) Strat es for the desi i of drugs targeting RNA and RNA-protein complexes. Angew. Chem. Int. Ed. EngJ., 39, 1890-905. 

Over the past two decades, QMF-based quantification assays have become the technique of choice for quantification of drug candidates and their metabolites. Combining a mass spectrometer with LC provides an additional degree of selectivity and makes the combined technique the method of choice for quantitative bioanalysis of drugs and metabolites. Among the mass spectrometer types, QMF are ideal for coupling with LC and atmospheric pressure ionization sources (ESI, APCI, APPI, DART, DESI, etc.) because QMFs have the lowest voltage requirements and vacuum requirements. 

The requirement that drugs be both effective and safe did not become law until 1962. The Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act passed in 1962 required the FDA to review all drugs released after 1938 for effectiveness as well as safety. This program established the Drug Efficacy Study Implementation (DESI) and the job was assigned to the National Academy of Sciences—National Research Council, which reviewed the data presented for each drug that had been submitted to the FDA. 

On the basis of the Drug Efficacy Study Implementation (DESI) review, which began in 1962, the FDA... 

In the past two decades, FDA has proceeded slowly but surely with the DESI programme implementing the NAS review of pre-1962 new drugs. 

Although still at a very early stage, ambient ionization methods, mostly DESI and DART, have been evaluated and used in the ADME studies for drug candidates. The fact that ambient ionization methods can analyze samples without sample preparation seems extremely attractive for bioanalysis as sample preparation is widely considered as the key bottleneck in bioanalysis. Also, the fact that samples can be analyzed... 

In addition to some early applications in bioanalysis, ambient ionization mass spectrometry has been used as an imaging tool to study drug distribution in tissue sections. Most of the work reported so far involved the use of DESI as the ambient ionization method. Compared to other mass spectrometry-based tissue imaging techniques such as MALDI and SIMS, DESI allows tissue samples to be analyzed under ambient conditions without sample preparation, which simplifies the procedure and prevents the redistribution of analytes during matrix deposition. A major drawback of DESI as an imaging tool is its relatively low spatial resolution (typically 250 pm) and therefore cannot be used for cellular or subcellular imaging. 

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