| A | B |
|---|
| drug development process | requires many steps to prove a drug is safe and effective |
| clinical trials | testing on humans |
| pre-clinical trials | testing on animals |
| research and developments | initial synthesis and analysis of promising drugs |
| Phase 1 Clinical trial | determines safety and toxixity |
| 20 - 80 volunteers / 9 - 18 months | Phase 1 Clinical trial |
| 100 - 300 patients / 1 - 3 years | Phase 2 Clinical trial |
| Phase 2 Clinical trial | determines safety and efficacy |
| Phase 3 Clinical trial | fully assess safety , efficacy and dosage; compares drug and placebo |
| 100s - 1000s of patients / 2 - 5 years | Phase 3 Clinical trial |
| Process technician | Responsible for tasks involved in monitoring and contol of manufacturing the product |
| Process engineer | designs, develops and operates the current manufacturing process |
| Quality control assistant | analyzes, raw materials, samples and finished formulations according to SOPs |
| Quality control associate | coordinates activities needed to document GMP and to update SOPs |
| Quality control engineer | Develops, revises, and maintains standards for converting raw materials into products |
| Quality control | involves checking the raw materials and product during every phase of its manufacture |
| Quality assurance | focuses on the overall system of manufacturing |
| Validation | proves that an SOP will consistently produce the product |
