Nonclinical studies
Encyclopedia
Nonclinical or Preclinical studies are research studies that are conducted, typically on animals, before a permit for a clinical trial
on humans can be obtained. Preclinical studies serve a vital role in the drug discovery and development processes. These studies can be used to identify lead compound
s likely to possess favorable biopharmaceutic and pharmacokinetic properties in humans. In addition, they can facilitate transition of discovery to development, as well as decrease the need for expensive and time-consuming clinical studies.
Preclinical studies include a wide range of studies in a variety of systems to characterize biopharmaceutic and pharmacokinetic properties. Systems used include: in vivo animal models, isolated perfused liver, kidney, intestine, hind limb and heart, Caco-2
cell monolayer absorption model, animal
and human liver
microsome
s. Studies include: bioavailability
studies, pharmacokinetic studies, prediction of oral absorption in humans, determination of mechanisms of intestinal absorption, assessment of transport, distribution and elimination of compounds, validated models for cytochrome P450 enzymes, metabolism studies in human liver microsomes, assessment of potential for metabolic drug
- drug interactions, analysis of drugs and metabolites in biological
matrices, synthetic chemistry, in silico modeling.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
on humans can be obtained. Preclinical studies serve a vital role in the drug discovery and development processes. These studies can be used to identify lead compound
Lead compound
A lead compound in drug discovery is a chemical compound that has pharmacological or biological activity and whose chemical structure is used as a starting point for chemical modifications in order to improve potency, selectivity, or pharmacokinetic parameters.Lead compounds are often found in...
s likely to possess favorable biopharmaceutic and pharmacokinetic properties in humans. In addition, they can facilitate transition of discovery to development, as well as decrease the need for expensive and time-consuming clinical studies.
Preclinical studies include a wide range of studies in a variety of systems to characterize biopharmaceutic and pharmacokinetic properties. Systems used include: in vivo animal models, isolated perfused liver, kidney, intestine, hind limb and heart, Caco-2
Caco-2
The Caco-2 cell line is a continuous line of heterogeneous human epithelial colorectal adenocarcinoma cells, developed by the Sloan-Kettering Institute for Cancer Research through research conducted by Dr...
cell monolayer absorption model, animal
Animal
Animals are a major group of multicellular, eukaryotic organisms of the kingdom Animalia or Metazoa. Their body plan eventually becomes fixed as they develop, although some undergo a process of metamorphosis later on in their life. Most animals are motile, meaning they can move spontaneously and...
and human liver
Liver
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion...
microsome
Microsome
In cell biology, microsomes are vesicle-like artifacts re-formed from pieces of the endoplasmic reticulum when eukaryotic cells are broken-up in the laboratory; by definition, microsomes are not ordinarily present in living cells....
s. Studies include: bioavailability
Bioavailability
In pharmacology, bioavailability is a subcategory of absorption and is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered...
studies, pharmacokinetic studies, prediction of oral absorption in humans, determination of mechanisms of intestinal absorption, assessment of transport, distribution and elimination of compounds, validated models for cytochrome P450 enzymes, metabolism studies in human liver microsomes, assessment of potential for metabolic drug
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
- drug interactions, analysis of drugs and metabolites in biological
Biological process
A biological process is a process of a living organism. Biological processes are made up of any number of chemical reactions or other events that results in a transformation....
matrices, synthetic chemistry, in silico modeling.
See also
- Drug Discovery Hit to LeadDrug discovery hit to leadEarly drug discovery involves several phases from target identification to preclinical development. The identification of small molecule modulators of protein function and the process of transforming these into high-content lead series are key activities in modern drug discovery. The Hit-to-Lead...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- Pre-clinical developmentPre-clinical developmentIn drug development, pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data is collected....
- U.S. Food and Drug Administration (FDA)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...