A product’s safety is measured by the magnitude of its measured harmful effects when it is administered. A safe product is one that has limited harmful effects at the dose to be used in the target population.
Transition from small-scale to production of larger and larger batches of material, eventually leading to processes that support manufacturing of industrial quantities of drug product.
A term used to indicate that an individual has become infected with HIV. Biologically, it refers to the development of antibodies to HIV, which is measured by clinicians as a biomarker of HIV infection. When people develop antibodies to HIV, they “seroconvert” from antibody-negative to antibody-positive (from HIV-negative to HIV-positive).
Also referred to as expiration dating period, the shelf life is the time period during which a drug product is expected to remain effective, provided that it is stored under the conditions defined on the container label.
small inhibitory RNA
A visit held prior to participant enrollment at a research center. The purpose is to acquaint all research center personnel with the relevant aspects of the trial prior to any participant enrollment. Components of this discussion include the clinical trial protocol, case report forms, missed visits, Institutional Review Board (IRB) practices, Institutional Ethics Committee (IEC) reporting requirements, adverse event reporting, etc.
site initiation visit
Small inhibitory RNA, or siRNA, is artificially created RNA [link to “RNA” entry] that prevents naturally occurring RNA from translating into protein. siRNA can be used as an effective tool to study biological processes in the laboratory. Some researchers are exploring the potential to use siRNA for disease treatment.
These are long-term, intermediate and accelerated studies used to establish or confirm the shelf life of a drug product or to make sure the drug product is still active and potent under a number of environmental conditions.
A basic process that a health-care provider or clinical trial investigator should follow for a certain type of patient or illness.