Which Preclinical Studies Make Or Break Your Drug Program?

The preclinical study is a vital first step to assess the safety and efficacy of drug candidates during the animal testing mandated by the Food and Drug Administration (FDA). They are required to be performed before considering first-in-human clinical trials to check any potential toxicity, PK/TP, and biomarker endpoints. Preclinical research services entail in-vivo and in-vitro testing; they are both used to test drug safety and effectiveness. Preclinical CRO (Contract Research Organization) is a support center providing proficiency in research and development that is highly required to steer the drug candidate from animal testing to the clinical phase.

FACTORS FOR PRECLINICAL RESEARCH

Once a lead compound is selected, preclinical research is started to determine the safety of the drug. The factors identified by the researchers are

• ADME information

• possible benefits

• mechanisms of action

• effects the drug has on gender, race or ethnicity groups

• how it interacts with other treatments

• side effects on the human body

• dosage and administration route

• success rate compared to other drugs

Preclinical trials test the new drug on animal species to discover its efficacy, toxicity, and pharmacokinetic information. It’s a risky process conducted to predict the impact it will have on human beings. Preclinical studies such as pharmacology and toxicology assist in moving the drug development forward.

PHARMACOLOGY

Pharmacodynamic and pharmacokinetic are both properties exhibited by a drug. They are used to measure and pinpoint the different results of the drug in the animal models; later filter out the undesirable components. Absorption, Distribution, Disposition, Metabolism, and Excretion (ADME) properties are used in the pharmacokinetic (PK) process to evaluate the safety of the drug and how it affects the body. It further helps to make appropriate decisions and design experiments and trials.

TOXICOLOGY

Clinical toxicological analysis is the key method to make sure of the safety of the test products that are beneficial to human beings. Toxicokinetics studies help us understand the entry of a substance in the body and what happens in the body when it enters. In vivo and in vitro studies are used to measure the toxicological activity of the drug product. Cell proliferation and phenotype is directly impacted by the in vitro studies; the toxicity profile of the drug is assessed by detecting effects on animal species by in vivo studies.

It is essential to pass your new drug through a series of trials and studies to make sure it is safe to release it in the market. The studies are made to detect any adverse effects or toxic levels in the drug. The studies need to provide detailed information on dosing and toxic levels for further advancement. If your studies are not designed properly, your medication could be dismissed as an error, that is why it is vital to have an expert preclinical CRO as well as regulatory awareness. During the animal testing, treatment ethics and regulations set for animals in preclinical research must be followed.

NorthEast BioLab offers preclinical research services which consist of biomarker assay testing, the bioanalysis of drug candidates during in-vitro and in-vivo studies, method development, validation, and transfer, etc. Our experienced and skilled professionals can assist you with a variety of testing obligations and regulatory difficulties.

Maria Brown is a medical expert who blog on patient safety and drug efficacy. She’s working for a top medical equipment company. Maria Brown has granted a large online following for herself as an expert medical thought leader.