A comprehensive approach for drug safety assessment.

Content Provider	Semantic Scholar
Author	Li, Albert Bollard Peter J. Klenow Huiyu
Copyright Year	2004
Abstract	A comprehensive, multidisciplinary approach is proposed here for the development of a drug with an acceptable safety profile. Key parameters to be considered for drug safety evaluation based on this comprehensive approach include the following: (1) Pharmacology: Possible toxicity due to drug-target interactions, including interactions with unintended molecular targets, or with molecular targets in unintended organs. (2) Chemistry: Chemical scaffolding and side-chains with safety concerns. (3) Toxicology: Toxicity in animals in vivo, and in relevant animal and human cells in culture. (4) Drug metabolism and pharmacokinetics: Safety concerns due to toxification or detoxification, organ distribution, clearance and pharmacokinetic drug-drug interactions. (5) RISK FACTORS: Physiological, environmental and genetic factors that may enhance a patient's susceptibility. It is proposed that this integrated, multidisciplinary approach to safety evaluation may enhance the accuracy of the prediction of drug safety and thereby the efficiency of drug development.
Starting Page	27
Ending Page	33
Page Count	7
File Format	PDF HTM / HTML
Alternate Webpage(s)	https://invitroadmet.com/wp-content/uploads/2018/02/Li-2004-A-comprehensive-approach-to-drug-safety-evaluation.pdf
PubMed reference number	15522259v1
Volume Number	150
Issue Number	1
Journal	Chemico-biological interactions
Language	English
Access Restriction	Open
Subject Keyword	Adverse reaction to drug Organ Patients drug development
Content Type	Text
Resource Type	Article