Drug development commercial assay kits

The Use of Commercial Assay Kits for PK/PD Analysis in Drug Development... 

THE USE OF COMMERCIAL ASSAY KITS FOR PK/PD ANALYSIS IN DRUG DEVELOPMENT... 

Commercial kits are usually supplied with calibration standard material. This may be in the form of a single vial of product from which a calibration curve can be constructed by serial dilution, or it may be a series of vials of ready-to-use standards with concentrations representative of the method s analytical range. For the purposes of assays used in drug development, it is often the case that the user will require a larger amount of calibration material, or a larger number of calibrator levels than is supplied. In the latter case, it is often possible to produce additional calibration standards from those provided either by dilution or by the mixing of those supplied. 

The evaluation of a number of immunoassay diagnostic kits was undertaken to determine their usefulness in a regulatory analytical laboratory environment in the food, feed and pesticide areas. Four rapid enzyme immunoassay tests for the detection of aflatoxin residues at the 20 ppb level in animal feeds were compared to the official HPLC procedure. In the pesticide area, a commercial pentachlorophenol competitive inhibition assay for residues in water was investigated as to its applicability to poultry and pork liver matrices. In addition, an ELISA screening procedure for the herbicide fusilade was developed. Modifications were incorporated into the rapid immunoband 1-2 Test procedure for the detection of motile Salmonella in various food and animal feed products resulting in quicker analysis than the standard culture method. Also, a comparative evaluation of a Quik-Card Test for sulphamethazine drug residues in pork urine, liver and muscle tissue, is described. 

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