Glossary

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  • Exploratory trialsExploratory trials are developed to select compounds or targeted medicines or approaches based on human data rather than animal data. They are conducted early in Phase I of the clinical development process, which involve limited human exposure, have no therapeutic intent, and are not intended(...)
  • ExtractablesCompounds that can be extracted from plastic or coatings of a container or closure system in direct contact with an active substance or medicinal product. Regulatory guidelines stipulate that an extractable profile should be determined for all materials in contact with the medicine or patient(...)
  • Federaal Agentschap voor Geneesmiddelen en GezondheidsproductenBelgian National Competent Authority. http://www.fagg-afmps.be/"
  • FAGGBelgian National Competent Authority. http://www.fagg-afmps.be/"
  • Federaal Kenniscentrum voor de gezondheidszorgBelgian Health Care Knowledge Centre. https://kce.fgov.be"
  • KCEBelgian Health Care Knowledge Centre. https://kce.fgov.be"
  • Food and Drug AdministrationUSA National Competent Authority. http://www.fda.gov/"
  • FDAUSA National Competent Authority. http://www.fda.gov/"
  • FormulationA formulation is a mixture of different chemical substances prepared according to a specific method to create a medicinal product.
  • FraudFraud is an intentional act of deception. An example of fraud within a research setting might be a deliberate attempt to fabricate data or present data in a misleading way. Fraud does not include honest errors or poor research processes, unless it is done with an intention to deceive. In(...)

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