Module 18 - Drug Device Combinations and Other Technologies

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PHASE 3 – LARGE NUMBERS OF PATIENTS

Studies cover  Final establishment of the therapeutic profile: • Dosage and types of administration • Contraindications • Precautionary measures  Proof of efficacy and safety in long ‐ term administration  Demonstration of therapeutic advantage versus comparators and/or placebo  Clarification of any interactions with other medications

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 Post ‐ marketing trials  Studies cover: • Dosage optimisation • Drug –drug interactions • Additional indications • Epidemiology and any post marketing surveillance required by regulatory authorities PHASE 4

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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