Chapter 18: Drug Safety Evaluation in Special Population

Chapter 18: Drug Safety Evaluation in Special Population

Author: Mrs. Saba Ruksaar
Volume: 01
First Online: 31 August 2024
Pages: 272-289
DOI:

Abstract

Drug safety evaluation in special populations is a critical aspect of clinical pharmacology, ensuring that medications are safe and effective across diverse groups. Special populations include pregnant women, children, the elderly, and individuals with comorbidities or genetic variations. These groups often have unique physiological characteristics that can alter drug pharmacokinetics and pharmacodynamics, increasing the risk of adverse drug reactions (ADRs) or therapeutic failure. Evaluating drug safety in these populations involves tailored clinical trials, dose adjustments, and careful monitoring to account for altered metabolism, organ function, and drug interactions. Regulatory guidelines often require specific studies to assess drug effects in these populations, as their responses may differ significantly from the general population. This approach ensures that drug therapy is optimized, reducing the risk of harm and improving treatment outcomes in vulnerable groups.

Keywords: Drug Safety Evaluation, Special Populations, Clinical Pharmacology, Pregnant Women, Children, Elderly, Comorbidities