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Nat Rev Drug Discov. 2003 Jul;2(7):542-53.

Making better drugs: Decision gates in non-clinical drug development.

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MDS Pharma Services, 3504 Proprietor Way, Raleigh, North Carolina 27612, USA.


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.

[Indexed for MEDLINE]

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