title: Making better drugs: Decision gates in non-clinical drug development.
abstract: Drug development is a risky business. Success or failure often depends on selecting one or two molecules for development from many choices offered by the engines of high-throughput discovery. A lead candidate needs to possess adequate bioactivity, appropriate physical-chemical properties to enable formulation development, the ability to cross crucial membranes, reasonable metabolic stability and appropriate safety and efficacy in humans. Predicting how a drug will behave in humans before clinical testing requires a battery of sophisticated in vitro tests that complement traditional in vivo animal safety assessments. This review discusses how to strategically identify which non-clinical studies should be performed to provide the required guidance and comfort to stakeholders involved in clinical drug testing.
authors.affiliation: MDS Pharma Services, 3504 Proprietor Way, Raleigh, North Carolina 27612, USA. fred.protchard@mdps.com
authors.forename: J Fred
authors.initials: JF
authors.lastname: Pritchard
authors.forename: Malle
authors.initials: M
authors.lastname: Jurima-Romet
authors.forename: Mark L J
authors.initials: ML
authors.lastname: Reimer
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Mortimer
authors.forename: Brenda
authors.initials: B
authors.lastname: Rolfe
authors.forename: Mitchell N
authors.initials: MN
authors.lastname: Cayen
mesh_terms: D000042:Absorption; D000818:Animals; D015195:Drug Design; D006801:Humans; D014116:Toxicology