Therapeutic Drug Monitoring

The drug dosage is regulated through the measurement of serum/plasma drug levels. It is more likely to produce the desired therapeutic effect without toxicity.

The Therapeutic effects are initiated through interaction of the drug with receptors on the cells of the target tissue.

The therapeutic effects are proportional to the drug concentration at the receptor site.

It is useful to monitor serum/plasma levels when one or more of the following conditions occur:

The drug has a narrow therapeutic range.

The drug does not produce the desired therapeutic.

Secondary disease alters drug utilization.

In India, there are strict guidelines governing the manufacture, sale, import, export and clinical research of drugs. The following Acts and Rules are to be strictly followed: (http://cdsco.nic.in/).

The Drugs and Cosmetics Act, 1940.

The Pharmacy Act, 1948.

The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.

The Narcotic Drugs and Psychotropic Substances Act, 1985.

The Medicinal and Toilet Preparations (Excise Duties) Act, 1956.

Enzyme Immunoassay (EIA) is an adequate sensitive test with specificity.

Confirmatory testing may be done by Gas chromatography/Mass spectrometry (GC/MS).

Drug Toxicity Therapeutic Levels

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