Research

Clinical trial phases – Phase 1

Clinical trial phases - Phase 1 1 MED4MIN.com Medicine Made Easy Research
Image Source: Shutterstock
"Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or the desired effect is seen. The drug may help patients, but Phase I trials are to test a drug’s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial." - NCCN definition

A Phase I clinical trial evaluates the best way to administer a drug, its frequency, and dose, the maximum tolerated dose (MTD), and side effects. Tolerability, pharmacokinetics, and pharmacodynamics are evaluated.

These studies determine, most importantly, if the treatment is safe.

Trials usually include 20 to 100 patients and are monitored by the clinical researcher. Doses are increased if there are no severe side effects and patients are tested to determine if he or she is responding to the therapy. These escalation dose studies are used to determine the best and safest dose that can be administered and is a fraction of the dose that caused harm during animal testing.

🔐 Locked content.
Sign in or create an account
and receive access.

Rate this post

Click on a star to rate this post

Average rating / 5. Vote count:

We are sorry that this post was not useful for you!

Let us improve this post!



Become A Patron →


Legal Disclaimer:
Some of the publications on MED4MIN are meant for commercial use. Some of the publications are protected by copyright law and are for educational or entertainment purposes only. MED4MIN is NOT a marketplace - all sales are done off the platform. You have no right to use any of the content without the explicit agreement of the author and MED4MIN.com.

1 Comment

Use Imgur to upload and share images! Just copy the link!

New here? Get connected!

Join the community and get access to premium content. Created by professionals for professionals.

@peepso_user_10(Teodora Kasemiyar)
Interesting!
3 weeks ago



Go To