Module 18 - Drug Device Combinations and Other Technologies

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Therapeutic exploratory trial in patients  Usually in a hospital with patients  To determine safety and efficacy and possibly proof of concept  Studies cover • First controlled trials on efficacy in patients • Bioavailability testing of formulations • Dose definition • Proof of concept? PHASE 2 – PATIENTS

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Therapeutic confirmatory trial in patients  Patient numbers depends on rarity of disease state  To determine safety and efficacy on a large scale  Studies form basis of MA (NDA) licence application PHASE 3 – LARGE NUMBERS OF PATIENTS

REG2000 © 2020 NSF Intl. These materials may not be used, copied, distributed or altered other than as permitted by NSF Intl. All rights reserved.

NSF Confidential

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