ADME Absorption, Distribution, Metabolism, and Excretion:
it describes the disposition of a pharmaceutical compound within an organism
is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in unnatural locations or concentrations) and biotics (macromolecules, proteins, DNA, large molecule drugs, metabolites) in biological systems
A biomarker, or biological marker, is an indicator of a biological state. It is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. It is used in many scientific fields.
An apparatus, such as a large fermentation chamber, for growing organisms such as cellsin silico model: In silico is an expression used to mean "performed on computer or via computer simulation."
are distinct families of cells grown in culture.
a systematized collection of data that can be accessed immediately and manipulated by a data-processing system for a specific purpose.
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
Drug Induced Liver Injury (DILI):
Inflammation of the liver due to an adverse reaction with a drug
is the biochemical modification of pharmaceutical substances by living organisms, usually through specialized enzymatic systems. This is a form of xenobiotic metabolism.
any chemical compound used in the diagnosis, treatment, or prevention of disease or other abnormal condition.
a parenchymal liver cell that performs all the functions ascribed to the liver
HepaRG cell line:
HepaRG is an immortalized cell line of the liver that can be differentiated into hepatocytes which retain many characteristics of primary human hepatocytes
Hep G2 cells:
A HCC derived human hepato-carcinoma cell line (ATCC No. HB-8065) from liver tissue of a 15 year old Caucasian American male with a well differentiated hepatocellular carcinoma.
hES cell: Human embryonic stem cell
In vitro cell toxicity testing:
is the scientific analysis of the effects of toxic chemical substances on cultured mammalian cells.
ITS Integrated Testing Strategy:
An ITS is an approach that integrates different types of toxicological data and information into a decision-making process for the safety of a chemical. In addition to the information from individual assays, test batteries, and/or tiered test schemes, integrated testing strategies may incorporate approaches such as weight-of-evidence and exposure/ population data into the final risk assessment for a substance
Liver cell biology:
The liver cells are the major structural and cellular component of the liver, and are involved in various functions of the liver such as the formation and secretion of bile.
Idiosyncratic hepatotoxicity: Idiosyncratic drug liver injury occurs when agents cause non-predictable hepatotoxicity in susceptible individuals which is not related to dose and has a variable latency period.
The liver's lymphocyte population is selectively enriched in natural killer and natural killer.
Physiologically based pharmacokinetic (PBPK) models Physiologically-based Pharmacokinetic models:
These models apply a realistic mathematical descriptionof physiology and biochemistry to simulate ADME (Absorption, Distribution, Metabolism, Excretion) processes and assess the distribution of chemicals and their metabolites in the body throughout time. They are particularly adapted to interspecies extrapolation and can be calibrated based on in vivo, in vitro or in silico data.
Pluripotent stem cell line:
These cells are of embryonic origin (ES cells) or induced to pluripotency by genetic re-programmation of somatic cells from donors (iPS cells). They share two main attributes, unlimited self-renewal –which makes them formally immortal- and pluripotency, the ability to differentiate into any cell type of the body at any stage of differentiation
Preclinical test systems:
studies of the toxicology of a substance on animals and cells to prepare parameters for Phase I human subject clinical studies.
SOP: Standard Operating Procedure
Systems analysis is the study of sets of interacting entities, including computer systems analysis. This field is closely related to requirements analysis or operations research.
Data relating to the harmful (toxicological) effects of chemicals. This may include information from animal, human or non-animal (in vitro) tests.
A well characterised compound for toxicity testing.