Making Better Drugs: Decision Gates in Non-Clinical Drug Development

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 f...

Full description

Saved in:
Bibliographic Details
Published inNature reviews. Drug discovery Vol. 2; no. 7; pp. 542 - 553
Main Authors Pritchard, J. Fred, Jurima-Romet, Malle, Reimer, Mark L. J, Mortimer, Elisabeth, Rolfe, Brenda, Cayen, Mitchell N
Format Journal Article
LanguageEnglish
Published England Nature Publishing Group 01.07.2003
Subjects
Absorption
Animals
Decision-making
Drug Design
Humans
Management
Methods
Pharmaceutical industry
Pharmaceutical research
Product development
Toxicology
United States
Online AccessGet full text

Cover

More Information
Summary: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.
ISSN:1474-1776
1474-1784
DOI:10.1038/nrd1131