In Vivo Preclinical Studies

Unlike in vitro studies, in vivo studies take place within living organisms. Animal subjects are usually used in preclinical trials. Due to in vivo studies’ ability to demonstrate how a pharmaceutical affects the entire body rather than just isolated cells, they can overcome the major limitations of in vitro studies. However, in vivo studies also have their limitations, such as ethical considerations. Nonetheless, they remain a crucial part of preclinical research.

Fig.1 The process of drug development begins with the discovery of new drugs, which includes target selection and lead discovery. (Brake, 2017)

Animal Models Test

Drug candidates must undergo rigorous animal testing to further evaluate toxicity, metabolism, and overall efficacy before they can be tested in humans. For preclinical in vivo studies, rodents, rabbits, dogs, primates, and other vertebrate animal models are frequently used. Mice that share 95% of their genes with humans are very attractive models for assessing drug safety and efficacy at the preclinical phase.

Toxicology and Efficacy Study

One of the main reasons for drug failure is lack of safety and efficacy. A new therapeutic candidate must be shown not only to be effective against a target disease but also to be safe at the dose intended for human use. A pharmaceutical compound that exhibits favorable pharmacokinetics is more likely to be effective and safe, emphasizing the importance of a thorough preclinical pharmacokinetic evaluation to prevent failures in clinical trials. It is also necessary to perform toxicological evaluate in animal models before final selection of compounds because toxicity studies form the basis of INDAs (Investigational New Drug Applications).

Bioavailability and Bioequivalence in Drug Development

Bioavailability refers to how effectively and efficiently the body absorbs and utilizes the active pharmaceutical ingredient or active moiety in a drug. It is assumed that two different formulations of the same drug or different drug products that are claimed to be bioequivalent are therapeutically equivalent or can be used interchangeably.

The Need for In Vivo Research

The drug discovery process usually begins with the identification of a therapeutic target, followed by the selection of candidates for preclinical testing. Drug candidates that demonstrate safety and efficacy through both in vitro and in vivo studies can advance to clinical trials for further testing. In vivo research is critical to drug development because it allows the assessment of biochemical and physiological properties of drugs, especially the absorption of drug substances, drug-drug interactions, and adverse effects that cannot be observed or characterized in vitro. The challenges of in vivo studies can be overcome by selecting animal models that can illustrate the effects of drug candidates on human systems.

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Reference

1. Brake, K.; et al. In vivo Studies for Drug Development via Oral Delivery: Challenges, Animal Models and Techniques. Pharm Anal Acta. 2017: 2153-2435