Sandbox gc: Difference between revisions
Jump to navigation
Jump to search
No edit summary |
No edit summary |
||
Line 1: | Line 1: | ||
__NOTOC__ | __NOTOC__ | ||
{| class="wikitable" | |||
{|class="wikitable | |||
|- | |- | ||
! colspan="5" style="background-color: #CCEEEE;" |Summary of clinical trial phases | |||
|- | |- | ||
!Phase | |||
!Primary goal | |||
!Dose | |||
!Patient monitor | |||
!Typical number of participants | |||
|- | |- | ||
| | |Preclinical | ||
|Testing of drug in non-human subjects, to gather [[efficacy]], [[toxicity]] and [[pharmacokinetic]] information | |||
|unrestricted | |||
|scientific researcher | |||
|not applicable (''[[in vitro]]'' and ''[[in vivo]]'' only) | |||
|- | |- | ||
| | |Phase 0 | ||
|[[Pharmacokinetics]]; particularly, oral bioavailability and half-life of the drug | |||
|very small, subtherapeutic | |||
|clinical researcher | |||
|10 people | |||
|- | |- | ||
| | |Phase I | ||
|Testing of drug on healthy volunteers for [[dose-ranging]] | |||
|often subtherapeutic, but with ascending doses | |||
( | |clinical researcher | ||
|20–100 normal healthy volunteers (or for cancer drugs, cancer patients) | |||
|- | |- | ||
| | |Phase II | ||
|Testing of drug on patients to assess efficacy and side effects | |||
|therapeutic dose | |||
|clinical researcher | |||
|100–300 patients with specific diseases | |||
|- | |- | ||
| | |Phase III | ||
|Testing of drug on patients to assess efficacy, effectiveness and safety | |||
| | |therapeutic dose | ||
|clinical researcher and personal physician | |||
|300–3,000 patients with specific diseases | |||
| | |||
| | |||
|- | |- | ||
|Phase IV | |||
|[[Postmarketing surveillance]] – watching drug use in public | |||
|therapeutic dose | |||
|personal physician | |||
|anyone seeking treatment from their physician | |||
|} | |} |
Revision as of 03:35, 24 October 2017
Summary of clinical trial phases | ||||
---|---|---|---|---|
Phase | Primary goal | Dose | Patient monitor | Typical number of participants |
Preclinical | Testing of drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information | unrestricted | scientific researcher | not applicable (in vitro and in vivo only) |
Phase 0 | Pharmacokinetics; particularly, oral bioavailability and half-life of the drug | very small, subtherapeutic | clinical researcher | 10 people |
Phase I | Testing of drug on healthy volunteers for dose-ranging | often subtherapeutic, but with ascending doses | clinical researcher | 20–100 normal healthy volunteers (or for cancer drugs, cancer patients) |
Phase II | Testing of drug on patients to assess efficacy and side effects | therapeutic dose | clinical researcher | 100–300 patients with specific diseases |
Phase III | Testing of drug on patients to assess efficacy, effectiveness and safety | therapeutic dose | clinical researcher and personal physician | 300–3,000 patients with specific diseases |
Phase IV | Postmarketing surveillance – watching drug use in public | therapeutic dose | personal physician | anyone seeking treatment from their physician |