Preclinical Research in Drug Development

Preclinical Research in Drug Development

Preclinical studies provide data about drug safety and efficacy in animals to determine if the drug should proceed to clinical testing in humans. Three important factors to consider when conducting preclinical research are pharmacodynamics, pharmacokinetics, and toxicology.

Pharmacodynamics: What does the drug do to the body?

Pharmacodynamics (PD) is the relationship between a drug and its biological effect. PD studies determine the potency, efficacy, and safety of a drug, including dose-response data and adverse events. They also determine the therapeutic index, or the ratio of the toxic dose to the concentration which produces a therapeutic effect.

Pharmacokinetics: What does the body do to the drug?

Pharmacokinetics (PK) is the study of how a drug moves through the body. This depends on how the drug is absorbed, distributed, metabolized, and excreted. Drugs administered orally are absorbed into the bloodstream via the gastrointestinal tract. The bioavailability, or amount of drug present in the circulation, is distributed amongst tissues and metabolized into pharmacologically active components and inactive metabolites. Clearance is then achieved by the kidneys and liver and the drug is excreted in the urine or feces. PK studies are helpful in determining administration routes and dosing schedules to be used in a subsequent clinical trial.

Toxicology: Is the drug safe?

Preclinical toxicology studies provide data on drug safety and help to determine a suitable starting dose for human testing. Early single-dose studies identify organs subject to toxic effects, while later studies mimic the intended clinical design in regards to treatment schedule and duration.

TransPharm Preclinical Solutions

The gold standard for in vivo pharmaceutical research is the mouse model. Although there are species-specific differences, humans and mice share 99% of their genomes which allows scientists to make predictions about clinical efficacy. TransPharm Preclinical Solutions has many established mouse models of infectious disease which can be used to study the pharmacodynamics, pharmacokinetics, and toxicology of drug candidates. Contact us to learn more or to request a free, no-obligation quote.

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