Table 10 Practical checklist to prepare for clinical trials with non-medicinal investigational products
Raw material | Â |
| Â | Manufacturer |
| Â | Source |
| Â | Production |
| Â | Quality control (characteristics) |
| Â | Toxicity studies in vitro, animals, humans |
Final product | Â |
| Â | Manufacturer/Pharmacist |
| Â | Pre-define the criteria the final product should meet |
| Â | Reconstitution protocols |
| Â | Sterilisation protocols |
| Â | Quality control (characteristics) |
| Â | Safety control |
| Â | Dosage/concentration analysis |
| Â | Contamination with relevant substances, e.g. endotoxion, heavy metals |
| Â | Shelf life |
| Â | Pharmacokinetics |
| Â | Toxicity studies in vitro, animals, humans |
Clinical data | Â |
| Â | Pharmacokinetics |
| Â | Subject characteristics |
| Â | Relevant literature |
Overall risk-benefit assessment | Â |
| Â | Administration route (reduce safety risks if possible) |
| Â | Mechanism of action (tissue specificity) |
| Â | Analysis of potential effect |
| Â | Manageability of potential effects |
| Â | Estimate the risk of side effects |
| Â | Pre-define how to manage potential effects |
| Â | Dosage (based on First-In-Man (FIM) guidelines based on the No Observed Adverse Effect Level (NOAEL) in non-clinical safety studies adjusted with allometric factors) |
| Â | Quantitative regular daily exposure |
| Â | Study design (e.g. dose-escalation or pilot study) |
| Â | Subject characteristics (medical history, age etc.) |
| Â | Appoint an independent data safety monitoring board |
|  | Predefine safety endpoints (Table 6) |
| Â | Perform/report interim analyses on safety criteria during the study. |