Home » CRO Diaries: How Does A Toxicologist Undertake Clinical Toxicology Analysis?

CRO Diaries: How Does A Toxicologist Undertake Clinical Toxicology Analysis?

by Nathan Zachary
toxicology studies

The clinical toxicological analysis comprises the research and prevention of disorders caused due to toxins, drugs, and chemicals. Clinical toxicology testing can be segregated into clinical chemistry and toxicology. Clinical chemistry includes assessing molecular changes in the body and interpreting biological tests. These tests can involve several chemical and medical screenings to evaluate the health or disease status. 

On the other hand, toxicology studies the effects of toxins and chemicals on the body. Toxicology services help assess the risk of exposure and evaluate the potential health threats to the public. Toxicology studies in drug development are concerned with the harmful effects of drug products on the body. It also includes estimating the doses that lead to toxicity. But how does a toxicologist conduct toxicology analysis? The following sections answer this question. The article will help us understand the approach by discussing several aspects of clinical toxicology analysis.

Clinical toxicology analysis

The initial toxicological evaluations happen during pharmacokinetics and pharmacodynamics assays. But what are pharmacodynamics and pharmacokinetics? Pharmacokinetics studies the drug movement throughout the body by assessing its absorption, distribution, metabolism, and excretion characteristics. On the other hand, pharmacodynamics studies the effect an organism has on the drug product. It consists of several pharmacodynamic biomarkers, such as Cmax and AUC values.

Before beginning clinical toxicology studies, sponsors conduct several preclinical toxicity studies to identify first-in-human doses. The maximum tolerated dose (MTD) is the most common approach to identify the highest drug dose that does not produce any toxic effects. MTD study involves a series of tests, including acute toxicity testing, short-duration dose escalation testing, and dose-ranging studies. These studies comprise several test animals with toxicity endpoints such as clinical pathology and clinical observations. 

Clinical toxicology deals with identifying drugs, chemicals, or toxins that may induce side effects in patients. Clinical toxicology analysis helps identify side effects, optimize therapeutic interventions or confirm disease diagnosis. It may further help determine the presence or absence of drugs and their metabolites and verify their compliance with their intended applications. Clinical toxicologists perform pharmacogenetic testing to understand adverse drug reactions or help select a specific drug for an individual patient.

Therapeutic drug monitoring is complementary to pharmacogenetic testing. Therapeutic drug monitoring measures drug concentration within a specific period to confirm that these concentrations are potentially toxic or subtherapeutic. Hence, therapeutic drug monitoring helps optimize drug doses by identifying an optimal therapeutic plasma drug concentration while reducing toxicity.

Germline pharmacogenetics evaluates genetic variations associated with drug disposition or drug response that may increase the risk of drug toxicity, reduce therapeutic benefit, or nonstandard dose requirements. The final objective of germline pharmacogenetics in clinical toxicity assessments is to reduce the count of nonresponders and prevent potential adverse drug reactions.

Also Read: Identifying And Avoiding The Pitfalls For Your Bioanalytical Assay Development

Finally, neonatal drug exposure may also have harmful effects. Studies have shown that neonatal drug exposure may lead to long-term developmental and behavioral deficits. However, the detection of drug effects largely depends on the use of the drug during pregnancy, analyte deposition, and drug stability. Timely toxicity detection is crucial for effective identification and management.

Clinical toxicological analysis has significant applications. Hence, toxicologists must employ robust techniques when conducting clinical toxicology analysis.

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