方法对比
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| I期临床试验× | 剂量-反应分析× | |
|---|---|---|
| 领域 | 流行病学 | 流行病学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1960s (formal regulatory framework established ~1963–1970s) | Conceptual roots 16th century; modern epidemiological application mid-20th century |
| 提出者≠ | Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines | Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill |
| 类型≠ | Interventional clinical study design | Quantitative analytical method |
| 开创性文献≠ | Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. DOI ↗ | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| 别名 | Phase 1 trial, first-in-human study, FIH study, dose-escalation study | exposure-response analysis, concentration-response modeling, dose-response modeling, DRA |
| 相关≠ | 6 | 4 |
| 摘要≠ | A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials. | Dose-response analysis quantifies the relationship between the magnitude of an exposure (the dose) and the probability or rate of an outcome (the response). It is a core analytical strategy in epidemiology and toxicology, providing evidence that increasing exposure systematically increases — or decreases — the risk of disease. A demonstrated dose-response gradient is one of Bradford Hill's classic criteria supporting causal inference. |
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