Ensuring the safety and efficacy of new drugs is paramount in the drug development process. This book explores the methodologies and regulatory frameworks used to assess drug safety and therapeutic effectiveness from preclinical studies through clinical trials. It covers risk assessment, pharmacovigilance, toxicology, and the design of robust clinical trial protocols. Additionally, the book addresses the challenges of balancing efficacy with safety, managing adverse events, and implementing strategies for benefit-risk evaluation. Designed for pharmaceutical scientists, clinical researchers, and regulatory professionals, the book provides essential knowledge for developing safe and effective new medications.
Aria Stevens is an expert dermatologist specializing in safety and efficacy assessments in new drug development, focusing on ensuring that novel dermatological medications meet rigorous standards for both safety and therapeutic effectiveness. Her research explores methodologies for conducting preclinical and clinical trials, evaluating adverse effects, and determining the optimal dosing regimens for new skin treatments. Aria has published extensively on the strategies for balancing drug efficacy with safety profiles, facilitating the development of innovative and reliable dermatological therapies. She has developed comprehensive safety and efficacy protocols that enhance the evaluation processes in drug development.