title: Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development.
abstract: Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations. While each transformation resulted in more effective and/or safer pharmaceuticals, overall attrition, cycle time, cost, numbers of animals used, and low probability of success for new products remain concerns, and pharmaceutical development remains a very high risk business proposition. In this manuscript we review pharmaceutical development since ancient times, describe its coevolution with animal experimentation, and attempt to predict the characteristics of future transformations.
authors.affiliation: Lewis B. Kinter, PhD, DABT, FATS is Principle Scientist at GLP Scientific Consulting in Unionville, Pennsylvania. Joseph J. DeGeorge, PhD, is Vice President of Safety Assessment and Laboratory Animal Resource at Merck & Co., Inc. in West Point, Pennsylvania.
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Kinter
authors.affiliation: Lewis B. Kinter, PhD, DABT, FATS is Principle Scientist at GLP Scientific Consulting in Unionville, Pennsylvania. Joseph J. DeGeorge, PhD, is Vice President of Safety Assessment and Laboratory Animal Resource at Merck & Co., Inc. in West Point, Pennsylvania.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: DeGeorge
mesh_terms: D032761:Animal Experimentation; D000818:Animals; D055808:Drug Discovery; D006801:Humans; D010146:Pain
keywords: animal and human experimentation; pharmaceutical development; pharmacology and toxicology; regulation; technology