Pharmacology — which is the study of the biomechanical or physiological effects of medicines and drugs on a cell, tissue, organ, or an organism — impacts the design of clinical studies significantly. Preclinical development and the planning stages in particular have a strong emphasis on pharmacology.

In 1970, the first World Health Organization report on clinical pharmacology called for more studies that determine the actions of drugs in human trials, according to a paper published in the Basic & Clinical Pharmacology & Toxicology journal. Greater priority was given to improving these drug studies in humans, which led clinical pharmacology to expand within drug development studies.

Often this area of expertise is used in preclinical research and early stages. The pharmacology information uncovered in Phase I trials is often used to further design the major aspects of Phase II and Phase III clinical trials, according to the U.S. Food and Drug Administration (FDA).

In fact, Phase I trials are often used to identify the safety and correct dosage for investigational drugs, which includes determining pharmacokinetic and pharmacodynamic properties of a particular medication. Pharmacodynamics is essentially uncovering how a particular medication affects the body, while pharmacokinetics is a study of the absorption, metabolism, distribution, and excretion of the drug itself.

There are multiple studies that scientists develop to determine the pharmacokinetics aspects of a drug, such as drug interactions, healthy vs. patient population studies, biomarkers, and pharmacogenomics.

One complicated process that researchers undergo during preclinical development is determining the dosing regimen that reaches target drug exposure in relevant populations. When designing a clinical study, single dose and multiple dose escalation studies need to be considered.

Researchers often need to follow a placebo-controlled, randomized trial for the first in-human study. Preclinical toxicology information is used to determine the starting dosage. The necessary data to gather includes safety information, the maximum tolerable dose, pharmacokinetic characteristics, steady-state parameters, and drug elimination evidence.

Conducting drug interaction studies is also critical to determining whether certain metabolizing enzymes or substrates stop or induce the operation of the relevant medication. A crossover design is often used and researchers mimic the clinical setting as best as possible during preclinical development.

The ultimate results that researchers hope for during drug development are medicines that reach the target site immediately at nontoxic concentrations, do not accumulate in other regions of the body, and do not significantly bind to plasma proteins. The researchers who focus their work on this area are called clinical pharmacologists and are composed of physicians, pharmacists, and scientists who work in academia, industry, and the government, according to the American Society for Clinical Pharmacology and Therapeutics website.

Within the laboratory setting, clinical pharmacologists work on drug metabolism and study biomarkers, genomics, and pharmacokinetics. Those in an office environment use this information to design and assess clinical studies, and follow regulatory guidelines for safe drug development. When it comes to the clinical setting itself, pharmacologists work directly with patients who are participating in experimental studies. These professionals research adverse reactions and negative drug interactions within patients.

Clearly, pharmacology plays a large role in designing the later stages of a clinical study. If your organization needs assistance with tailoring a preclinical pharmacology study, Pharma Models specializes in this area of research.

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Categories: Toxicology and Pharmacology

Tags: CRO, drug development, pharmacology, pre-clinical studies, tumor models