Module 18 - Drug Device Combinations and Other Technologies

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DRUG/MEDICINAL PRODUCT LIFECYCLE Research Programme (4 ‐ 10 years?) Targets Programmes Candidates Market Screening Patents

Clinical Trials

Phase 1

Pre ‐ Clinical Development (3+ years?) Pharmacology Safety

Tolerance Biobatches

Dosage

Efficacy

Phase 2

Clinical Development (3+ years?) Clinical Safety International CTs Scale ‐ up… Regulatory Submission

Phase 3

Commercialise (2+ years?) Register Product: Approval

Phase 4

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Human pharmacology trial with no evidence of potential benefit to the proposed participants  Usually in a Phase 1 unit  Single dose in increasing size  Repeated dose  To determine • Tolerability and toxicity • Dose ‐ effect relationship and duration of effect • Side effects (some) • Pharmacokinetics in humans PHASE 1 – FIRST TIME IN MAN

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

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