Biotech Acronyms and Abbreviations

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Across
  1. 1. a massively parallel sequencing technology that offers ultra-high throughput, scalability, and speed
  2. 2. a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
  3. 5. a system for ensuring that products are consistently produced and controlled according to quality standards.
  4. 6. a commonly used analytical biochemistry assay to detect the presence of a ligand in a liquid sample using antibodies directed against the ligand to be measured
  5. 8. any systematic process of determining whether a product or service meets specified requirements
  6. 10. a general term used to describe the quality guidelines and regulations applied in the pharmaceutical industry
  7. 11. analytical technique that is used to measure the mass-to-charge ratio of ions, used to elucidate the chemical identity or structure of molecules and other chemical compounds.
  8. 12. a system of maintaining standards in manufactured products by testing a sample of the output against the specification.
  9. 14. a federal agency responsible for protecting and promoting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals and other things
  10. 15. a division of the U.S. Food and Drug Administration that monitors most drugs
  11. 16. a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical
  12. 17. A company hired by another company or research center to take over certain parts of running a clinical trial.
  13. 18. a drug or biological drug that has not been approved for general use by the FDA
Down
  1. 1. a formal proposal that the FDA approve a new pharmaceutical for sale and marketing
  2. 3. a software-based solution with features that support a modern laboratory's operations.
  3. 4. equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses
  4. 5. are guidelines for managing non-clinical health and environmental studies effectively. They cover how studies are planned, conducted, recorded, and reported
  5. 7. methods for demonstrating that the equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements.
  6. 9. a regulatory agency of the United States Department of Labor that assures safe and healthy working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education, and assistance
  7. 10. a physical separation method where volatile mixtures are separated and analyzed
  8. 13. the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States.
  9. 15. Center within FDA that regulates biological products for human use under applicable federal laws
  10. 17. the national public health agency of the United States