| A | B |
|---|
| Technology | The use of scientific knowledge and tools to solve problems or make useful products |
| Biopharmaceuticals | Products derived using living organisms to produce or modify the structure and/or functioning of plants or animals with a medical or diagnostic use |
| Bioprocessing | Procedure in which microorganisms, living cells or their components are used to produce a desired end product |
| Biotechnology | Use of living organisms and biological processes to solve problems or make useful products |
| Clinical Trial | A research study designed to answer specific questions about vaccines or new therapies or new ways of using know treatments by testing them in humans, specifically to determine whether they are safe and effective |
| Food and Drug Administration | The agency of the USDHHS that regulates the testing of experimental drugs and approves new drugs and medical products based on evidence of their safety and efficacy |
| Gene Therapy | The replacement of a defective gene in an organism suffering from a genetic disease |
| Genetic Engineering | The technique of removing, modifying, or adding genes to a DNA molecule in order to change the information it contains |
| Genetically Modified organism | An organism whose genetic material has been altered using recombinant DNA technology |
| Good Manufacturing Practice | A set of minimum standards enforced by the Food and Drug Administration to endure the safety and purity of drug products manufactured in the United States |
| Placebo | An inactive substance that looks like the drug that is being tested in a clinical trial. |
| Quality Assurance | A set of activities that ensures product quality by setting up and checking the procedures in the standard operating procedures and documentation |
| Quality Control | Involves checking the raw materials and product during every phase of its manufacture |
| Recombinant DNA technology | The laboratory manipulation of DNA. The manipulated DNA is inserted into a living organism. |
| Standard Operating Procedure | A document that defines in detail every step of only one particular process so it can be performed exactly the same way every time. |
| Synthesis | Preparing the materials; mixing and measuring chemicals and reagents |
| Purification | Separating the desired product from the by-product; end result is bulk product |
| Formulation | mixes active ingredient with other substances needed for final form |
| Final dosage formulation | containers are labeled and packaged |
