Healthy Volunteers
Why Use Healthy Volunteers?
Safety Assessment:
Testing on healthy individuals helps isolate the drug’s effects without interference from underlying conditions, making it easier to determine safety and dosage ranges.
Drug Processing:
Healthy volunteers provide a clear baseline for understanding how the drug is absorbed, distributed, metabolized, and excreted. This data ensures accuracy when the drug is later tested on patients.
What Healthy Volunteers Should Know
Informed Consent:
Volunteers are thoroughly informed about the trial’s purpose, procedures, risks, and their rights, including the ability to withdraw at any time.
Close Monitoring:
Participants are closely observed for side effects, ensuring safety throughout the study.
Contribution to Medical Science:
By participating, volunteers help advance treatments that benefit future patients, contributing to
critical knowledge for safe drug development.
Key Points About Healthy Volunteers
Purpose: Assess safety and determine proper dosage of a new drug.
Selection Criteria: Healthy adults (18–75 years old) with no significant medical conditions.
Screening Process: Includes physical exams, blood tests, and sometimes ECGs to confirm baseline health.
