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21st Century Drug Development: Advances, Opportunities and Challenges

21st Century Drug Development: Advances, Opportunities and Challenges ATLA 37, 335–339, 2009 335 Editorial 21st Century Drug Development: Advances, Opportunities and Challenges According to US Food & Drug Administration A Time to Critically Evaluate All (FDA) statistics, only around one in every ten new Preclinical Methods? medicinal products that progress to clinical trials ever reaches the registration stage, with approxi- Traditionally, human physiology and diseases mately half of all drug failures attributed to prob- have been modelled by taking only a single factor, lems with efficacy, bioavailability, toxicity or or a handful of factors, into consideration. This clinical safety, which were not anticipated follow- approach has resulted in transgenic animals that ing preclinical studies. The statistics also indicate express a single human gene, being considered as that the number of new drug submissions has valid models, without a sufficient understanding of fallen over the last few years. Furthermore, the functional equivalence of the expression prod- although actual market withdrawals are rare, uct in the test species and in humans or, indeed, adverse drug events have more than doubled since sufficient monitoring of other physiological and 1998, and around 20% of successfully marketed biochemical factors that might determine the role drugs have their later use restricted by so-called http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Alternatives to Laboratory Animals SAGE

21st Century Drug Development: Advances, Opportunities and Challenges

Bhogal, Nirmala
Alternatives to Laboratory Animals , Volume 37 (4): 5 – Sep 1, 2009
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References (13)

Publisher
SAGE
Copyright
© 2009 Fund for the Replacement of Animals in Medical Experiments
ISSN
0261-1929
eISSN
2632-3559
DOI
10.1177/026119290903700401
Publisher site
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Abstract

ATLA 37, 335–339, 2009 335 Editorial 21st Century Drug Development: Advances, Opportunities and Challenges According to US Food & Drug Administration A Time to Critically Evaluate All (FDA) statistics, only around one in every ten new Preclinical Methods? medicinal products that progress to clinical trials ever reaches the registration stage, with approxi- Traditionally, human physiology and diseases mately half of all drug failures attributed to prob- have been modelled by taking only a single factor, lems with efficacy, bioavailability, toxicity or or a handful of factors, into consideration. This clinical safety, which were not anticipated follow- approach has resulted in transgenic animals that ing preclinical studies. The statistics also indicate express a single human gene, being considered as that the number of new drug submissions has valid models, without a sufficient understanding of fallen over the last few years. Furthermore, the functional equivalence of the expression prod- although actual market withdrawals are rare, uct in the test species and in humans or, indeed, adverse drug events have more than doubled since sufficient monitoring of other physiological and 1998, and around 20% of successfully marketed biochemical factors that might determine the role drugs have their later use restricted by so-called

Journal

Alternatives to Laboratory Animals – SAGE

Published: Sep 1, 2009

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