Name the 6 phases of drug development
- Lead ID
- Pre-Clinical
- Phase 1
- Phase 2
- Phase 3
- File & Launch
(7. Life Cycle Management)
When is the Critical Time in drug development
It is the point during phase 2 when the Medchem and Supply Route is adjusted to the manufacturing route as the small pilot is transferred to the full pilot. (Most drugs fail during this phase)
Number of patients during the 3 phases of clinical trials
Phase 1: <100 (Healthy)
Phase 2: <500 (With Disease)
Phase 3: <5000
When is scale up risk at its maximum
Between Phase 3 and File & Launch (i.e. when there is a transfer from full pilot to manufacturing)
Time taken to get drug onto market
10 - 15 years
Cost to get a drug on the market
$0.5 - 2 billion
Fraction of drugs to make it onto market
1/10000
Define GMP
Good Manufacturing Practice: Quality Assurance that ensures medicinal products are consistently produced and controlled to the quality standards appropriate for their intended use
Define Fit for Purpose
- Right Product
- Right Dosage
- Free from Contamination
- No Deterioration
- Right packaging
- Properly sealed (protected against contamination)
- Compliant with all legal regulations
Why is it important to take records
- Pass information to colleagues
- Demonstrates that work was done
- Log results and observations
- Document Decisions
- Report Justifications, errors, investigations
- Provides traceability
- Details and evaluates outcomes
Define Space-Time Yield
Mass Product/ (Reactor Volume x Reaction Time)
Application of Space-Time-Yield
- Current Process = 100%
- Assesss changes by quantative impact & significance
e. g. yield increases by 10% (STY = 110%) etc
