Сравнение на методи

	Клинично изпитване Фаза I	Анализ „доза-отговор“
Област	Епидемиология	Епидемиология
Семейство	Process / pipeline	Process / pipeline
Година на възникване	1960s (formal regulatory framework established ~1963–1970s)	Conceptual roots 16th century; modern epidemiological application mid-20th century
Създател	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
Тип	Interventional clinical study design	Quantitative analytical method
Основополагащ източник	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
Други названия	Phase 1 trial, first-in-human study, FIH study, dose-escalation study	exposure-response analysis, concentration-response modeling, dose-response modeling, DRA
Свързани	6	4
Резюме	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.