| Citation | Subject |
|---|
| 21 CFR Part 58 | Good Laboratory Practice for nonclinical laboratory studies |
| 21 CFR Part 312 | Investigational New Drug application; IND safety reporting (§312.32) |
| 21 CFR Parts 50 / 56 | Protection of human subjects (informed consent) / Institutional Review Boards |
| 21 CFR Parts 210 / 211 | Current Good Manufacturing Practice for finished pharmaceuticals |
| 21 CFR Part 314 / 601 | NDA / BLA applications and postmarketing reporting |
| 21 CFR 201.56–201.57 | Physician Labeling Rule content and format |
| FDAAA 801 / 42 CFR Part 11 | ClinicalTrials.gov registration and results submission |
| ICH M3(R2), S1–S8, M7 | Nonclinical safety study design and timing |
| ICH E6(R3), E8(R1), E9(R1) | GCP, general considerations for clinical studies, estimands |
| ICH Q1A(R2), Q2(R2), Q3A–D, Q8–Q12 | Stability, analytical validation, impurities, pharmaceutical quality |
| NIH GDS / DMS Policy (2023) | Genomic and Data Management & Sharing plans for NIH-funded work |
| NIH sIRB Policy; NIH Inclusion Policy | Single IRB for multi-site studies; inclusion of women and minorities |
| Term | Meaning | Favorable direction |
|---|
| IC50 / EC50 | Concentration producing 50% target inhibition / 50% cellular effect | Lower |
| Cmax / Tmax | Peak plasma concentration / time to peak | Context-dependent |
| AUC | Area under the concentration–time curve; total systemic exposure | Must reach target exposure |
| t½ | Elimination half-life; drives dosing interval | Longer supports QD dosing |
| NOAEL | No-observed-adverse-effect level in the most sensitive species | Higher |
| Safety margin | Toxic exposure ÷ efficacious exposure | ≥10× commonly targeted |
| MRSD | Maximum recommended starting dose in humans | Derived, not chosen |
| p-value / CI | Probability of result by chance / plausible range for true effect | p<0.05; CI excluding null |