Quick Guide to Good Clinical Practice by Cemal Cingi & Nuray Bayar Muluk

Author:Cemal Cingi & Nuray Bayar Muluk
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

12.8 Summary of Clinical Trial Phases

Preclinical

Primary goal: Testing of a drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information

Dose: Unrestricted

Patient monitor: A graduate-level researcher (Ph.D.)

Typical number of participants: Not applicable (in vitro and in vivo only) [1]

Phase 0

Primary goal: Pharmacodynamics and pharmacokinetics, particularly oral bioavailability and half-life of the drug

Dose: Very small, subtherapeutic

Patient monitor: Clinical researcher

Typical number of participants: Ten people

Notes: Often skipped for phase I [1]

Download

Copyright Disclaimer:
This site does not store any files on its server. We only index and link to content provided by other sites. Please contact the content providers to delete copyright contents if any and email us, we'll remove relevant links or contents immediately.