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. 2006 Sep;2(3):217-35.

Immunoassay Methods and their Applications in Pharmaceutical Analysis: Basic Methodology and Recent Advances

Ibrahim A Darwish  1
Affiliations

Immunoassay Methods and their Applications in Pharmaceutical Analysis: Basic Methodology and Recent Advances

Ibrahim A Darwish. Int J Biomed Sci. 2006 Sep.

Abstract

Immunoassays are bioanalytical methods in which the quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. Immunoassays have been widely used in many important areas of pharmaceutical analysis such as diagnosis of diseases, therapeutic drug monitoring, clinical pharmacokinetic and bioequivalence studies in drug discovery and pharmaceutical industries. The importance and widespread of immunoassay methods in pharmaceutical analysis are attributed to their inherent specificity, high-throughput, and high sensitivity for the analysis of wide range of analytes in biological samples. Recently, marked improvements were achieved in the field of immunoassay development for the purposes of pharmaceutical analysis. These improvements involved the preparation of the unique immunoanalytical reagents, analysis of new categories of compounds, methodology, and instrumentation. The basic methodologies and recent advances in immunoassay methods applied in different fields of pharmaceutical analysis have been reviewed.

Keywords: antibodies; drug discovery; immunoassay; pharmaceutical analysis; pharmaceutical industry.

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Figures

Figure 1
Figure 1
Schematic diagram for the competitive immunoassays.
Figure 2
Figure 2
Schematic diagram for the non-competitive immunoassay.
Figure 3
Figure 3
Schematic diagram for the liposome immunoassay.
Figure 4
Figure 4
Schematic diagram for production of monoclonal antibodies.
Figure 5
Figure 5
Schematic diagram of the competitive immunoassay for metal ions.
Figure 6
Figure 6
Principles of the cloned enzyme donor immunoassay. (A) In the absence of free drug, formation of a complete tetrameric enzyme is inhibited, and no coloured product is generated after addition of substrate to the reaction mixture. (B) In presence of free drug, it competes with the enzyme donor (ED)-drug conjugate for anti-drug antibody binding sites. Complete active enzyme molecules are formed, which converts the colourless substrate into coloured product in proportional to the drug concentration. EA, enzyme acceptor.
Figure 7
Figure 7
Schematic diagram of displacement flow-injection immunoassay.
Figure 8
Figure 8
Schematic diagram for a reaction cycle of the flow-injection enzyme immunoassay.
Figure 9
Figure 9
Schematic diagram for the continuous-flow enzyme immunoassay for determination of aminoglycosides.
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