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Glossary Term
EU Regulation 2017/746 governing in vitro diagnostics, which replaced the IVDD with stricter evidence, post-market surveillance, and reclassification rules. Products legacy-listed under the IVDD may still carry transitional timelines, so registration status should be verified per product and per market.
Glossary Term
The goodness of fit statistic for the terminal elimination phase, adjusted for the number of time points used in the estimation of Lambda z.
Glossary Term
Mutually exclusive alternative forms of the same gene occupying the same locus on homologous chromosomes, differing in nucleotide sequence and governing the same biochemical and developmental process.
Glossary Term
Alternate Splicing is a process in which multiple protein isoforms or products are generated from a single gene as a result of splicing together different nonconsecutive exons during the processing of initially identical nascent transcripts of a gene into mature mRNA transcripts. An exon may be connected to any one of several alternative exons to form the mRNA and generate related proteins, often in a tissue or developmental stage specific manner.
Glossary Term
A statistical technique which helps in making inference whether three or more samples might come from populations having the same mean; specifically, whether the differences among the samples might be caused by chance variation.
Glossary Term
A type of protein made by B lymphocytes in response to a foreign substance (antigen). Each antibody only binds to a specific antigen, helping to destroy the antigen directly or by assisting white blood cells to destroy the antigen.
Glossary Term
The area between the x-axis and the curve given by the integrand. It is equal to the definite integral of a function. In the field of pharmacokinetics, the area under the curve (AUC) is the area under the curve in a plot of concentration of a drug in plasma against time. AUC is usually given for the time interval zero to infinity, and other time intervals are indicated.
Glossary Term
The sum of a set of values divided by the number of values in the set.
Glossary Term
A chromosome not involved in sex determination. The diploid human genome consists of a total of 46 chromosomes which includes 22 pairs of autosomes.
Glossary Term
Initiation of DNA base excision repair (BER) involves a DNA glycosylase that binds the altered deoxynucleoside in an extrahelical position and catalyzes cleavage of the base-sugar bond. Subsequently, an AP endonuclease or AP lyase activity incises the abasic site, followed by short-patch gap-filling, excision of the base-free sugar-phosphate residue, and ligation.
Glossary Term
The paired nucleotides in a DNA or RNA sequence.
Glossary Term
A characteristic of experiment design in which one or more groups involved (receiving, administering, or evaluating intervention) are unaware of which intervention any particular subject is receiving.
