Phase I Clinical Trial
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.
Izvorni zapis
Citati kopirani doslovno iz izvornog zapisa metode. Ne impliciraju nikakvu provjeru na razini tvrdnje.
- Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. · DOI 10.2307/2531693
- International Council for Harmonisation (ICH). (2016). ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). ICH Harmonised Guideline. · URL
Uređene tvrdnje
Tvrdnje pohranjene u knjigu dokaza, svaka s vlastitom procjenom.
Ovaj prikaz ne izmišlja procjenu tvrdnje kada knjiga dokaza nema nijednu.
Povezane metode
Generirano iz grafa metode i prikazano kao strojno predložene relacije — ne implicira se nikakva tvrdnja dokaza.