Process Development

Question 1

Name the 6 phases of drug development

Answer 1

1. Lead ID
2. Pre-Clinical
3. Phase 1
4. Phase 2
5. Phase 3
6. File & Launch
   (7. Life Cycle Management)

Question 2

When is the Critical Time in drug development

Answer 2

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)

Question 3

Number of patients during the 3 phases of clinical trials

Answer 3

Phase 1: <100 (Healthy)
Phase 2: <500 (With Disease)
Phase 3: <5000

Question 4

When is scale up risk at its maximum

Answer 4

Between Phase 3 and File & Launch (i.e. when there is a transfer from full pilot to manufacturing)

Question 5

Time taken to get drug onto market

Answer 5

10 - 15 years

Question 6

Cost to get a drug on the market

Answer 6

$0.5 - 2 billion

Question 7

Fraction of drugs to make it onto market

Answer 7

1/10000

Question 8

Define GMP

Answer 8

Good Manufacturing Practice: Quality Assurance that ensures medicinal products are consistently produced and controlled to the quality standards appropriate for their intended use

Question 9

Define Fit for Purpose

Answer 9

• Right Product
• Right Dosage
• Free from Contamination
• No Deterioration
• Right packaging
• Properly sealed (protected against contamination)
• Compliant with all legal regulations

Question 10

Why is it important to take records

Answer 10

• 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

Question 11

Define Space-Time Yield

Answer 11

Mass Product/ (Reactor Volume x Reaction Time)

Question 12

Application of Space-Time-Yield

Answer 12

• Current Process = 100%
• Assesss changes by quantative impact & significance
  e. g. yield increases by 10% (STY = 110%) etc