Adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...

(or

Adverse effect An adverse effect is an undesired harmful effect resulting from a Pharmaceutical drug, medication or other Surgery#Definitions, intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main ...

) prediction is the process of identifying potential adverse events of an investigational drug before they actually occur in a clinical trial. Predicting adverse events accurately represents a significant challenge to both the

pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, Vaccine, vaccinate them, or alleviate s ...

and academia, the reason being that our existing knowledge of

biology Biology is the scientific study of life. It is a natural science with a broad scope but has several unifying themes that tie it together as a single, coherent field. For instance, all organisms are made up of cells that process hereditar ...

disease A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that a ...

mechanisms (i.e. how a disease affects the healthy state of a human) and drug design is incomplete and sometimes incorrect. On top of that, the biological complexity and differences between living organisms is such that even if a treatment appears to work in the laboratory it may not work in humans. The occurrence of an adverse event during a

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

is a significant event, not only because of the risk to humans but also from a financial point of view for the organization (usually a

pharmaceutical company The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympt ...

) sponsoring the development of the drug in question. As a result, a lot of effort is continuously invested in this area and there are a number of approaches to predicting adverse events including cell line assays, animal models and computer based

in silico In biology and other experimental sciences, an ''in silico'' experiment is one performed on computer or via computer simulation. The phrase is pseudo-Latin for 'in silicon' (correct la, in silicio), referring to silicon in computer chips. It ...

models.

In silico In biology and other experimental sciences, an ''in silico'' experiment is one performed on computer or via computer simulation. The phrase is pseudo-Latin for 'in silicon' (correct la, in silicio), referring to silicon in computer chips. It ...

models are usually developed by extracting interactions and behaviors of biological systems either from the literature or from experimental data on a specific

or biological system and integrating this information in some kind of a

mathematical model A mathematical model is a description of a system using mathematical concepts and language. The process of developing a mathematical model is termed mathematical modeling. Mathematical models are used in the natural sciences (such as physics, ...

that can be used to understand and predict the behavior of a drug in an organism. Another relatively recent method is based on mining the scientific literature and correlating evidence from seemingly unrelated drugs or

medical condition A disease is a particular abnormal condition that negatively affects the structure or function (biology), function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medica ...

s. If done correctly this type of analysis can offer quite good predictive accuracy and significant lead times which translates to lower cost and development times for new drugs. While in silico methods aim to capture in depth the current knowledge of a biological system or a disease mechanism, they are still subject to the accuracy of that knowledge and may miss information that while seemingly unrelated, could in a multiply interconnected complex biological system prove highly relevant. This gap is addressed by the literature-based discovery approach which does not capture details to the same extent but compensates by offering complete coverage of the available knowledge from all potentially related fields.

External links

EntelosGNS
Clinical trials

See also

Further reading

External links