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Btc clinical
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All FDA approved medications and devices must go through the clinical trial process to be approved and put on the market for use. How does a clinical trial evaluate new, investigational medication? Clinical trials evaluate investigational medications and devices through a series of screenings, clinical visits, medical or behavioral tests and assessments, and a drug dosing schedule. Study coordinators, nurses, and doctors work with you throughout the process to collect information about how you are feeling and reacting to the treatment.
What is investigational medication? Investigational medication is tested in a laboratory setting. A clinical trial is used to test the safety and efficacy of an investigational medication. Investigational medications are not yet approved as safe or effective by the FDA; they are also not yet approved for sale by the FDA or any other government agencies or authorities. This is our preferred specimen type to receive for testing. Blood specimens can be sent at ambient temperature and express delivery should be arranged such that it arrives within 72 hours from collection, otherwise, they will need to be refrigerated.
DNA specimens can be sent at ambient temperature and express delivery should be arranged such that it arrives within 72 to 96 hours from when it was sent. Maternal Cell Contamination study recommended for placenta samples. Brain tissue and specimens under 1g are not recommended; they are only accepted with special circumstances and approval from a Lab Director. Fresh tissue samples may be accepted if received within 24 to 48 hours after collection and refrigeration is recommended for warm weather.
Frozen tissue samples must be stored at degrees Celsius immediately after collection and shipped with dry ice.
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