PDA Technical Glossary
PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.
The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.
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Naturally Occurring Endotoxin (NOE)
Endotoxin prepared from Gram-negative bacteria produced under defined conditions and with minimal nonchemical processing, e.g., centrifugation and filtration.(TR82)
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Nonclinical Laboratory Study
For this report, nonclinical laboratory study means in vivo or in vitro experiments, in which test articles are studied prospectively in test systems under laboratory conditions in order to determine their safety. The definition does not include: studies using human subjects or clinical studies, field trials in animals, or any basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics as described in ICH S6 and 21 CFR Part 58 (GLP).
Note: Also referred to as Preclinical, Toxicity or “Tox” studies. (TR56)
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Normal Dose
The therapeutic dose of a product as given on the approved product labeling. (TR29) (TR49)
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Nucleic Acid Sequence Based Amplification (NASBA)
An isothermal amplification method targeting RNA in which amplifications of RNA occurs via DNA intermediates. Each of the DNA templates can make 100 to 1000 copies of RNA amplicons, potentially resulting in the production of greater than a billion amplicons. (TR50)
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Nucleic Acid Standard
A sample with a precisely measured content of specific nucleic acid. A nucleic acid standard can be serially diluted to assess the limit of detection of an NAT assay or to create a standard curve for Q-PCR to determine the concentration of target nucleic acid. (TR50)