title: A comprehensive approach for drug safety assessment.
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.
authors.affiliation: Advanced Pharmaceutical Sciences, Inc., PMB #146, 6400 Baltimore National Pike, Baltimore, MD 21228, USA. lialbert@APSiences.com
authors.forename: Albert P
authors.initials: AP
authors.lastname: Li
mesh_terms: D000818:Animals; D002478:Cells, Cultured; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D015195:Drug Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D012449:Safety; D014116:Toxicology / Q000379:methods
chemical_list: D004364:Pharmaceutical Preparations