Healthy Skepticism Library item: 10700

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Stevens JL.
Future of toxicology--mechanisms of toxicity and drug safety: where do we go from here?
Chem Res Toxicol 2006 Nov; 19:(11):1393-401
http://pubs3.acs.org/acs/journals/doilookup?in_doi=10.1021/tx060213n

Abstract:

Recent high-profile drug withdrawals increase the pressure on regulators and the pharmaceutical industry to improve preclinical safety testing. Understanding mechanisms of drug toxicity is an essential step toward improving drug safety testing by providing the basis for mechanism-based risk assessments. Nonetheless, despite several decades of research on mechanisms of drug-induced toxicity and the application of various new technologies to preclinical safety assessment, the overall impact on preclinical safety testing has been modest. Assessing the risk of exposing humans to new drug candidates still depends on preclinical testing in animals, which in many, but not all cases, predicts outcomes in humans accurately. The following offers a perspective on the challenges and opportunities facing efforts to improve preclinical safety testing and outlines gaps and needs that must be addressed. A case is built for focusing solutions on defined problems within the current safety testing paradigm rather than imposing wholesale change. Targets for application of new technologies, including in silico screening, biomarkers, surrogate assays and ‘omic technologies, are outlined. Improving drug safety testing will depend on improving the application of mechanism-based risk assessment but will also require improving public and private collaborations in order to focus research regarding the mechanism of drug-induced toxicity on the most important problems.

Keywords:
Publication Types: Review MeSH Terms: Drug Approval Drug Evaluation, Preclinical* Drug Industry* Drug Toxicity* Humans Risk Factors Toxicology/trends*

Please
Click to Register

(read more)

then
Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts

If there is something you don't like, please tell us. If you like our work, please tell others.

Announcements

PharmedOut’s annual conference: Missing The Target: When Practitioners Harm More Than Heal

No Free Lunch is merging with Healthy Skepticism

Conference program: Pharma Knows Best? Managing Medical Knowledge

Prescrire’s proposals for France’s national conference on medicines policy

Pharmed Out Conference ‘Pharma Knows Best? Managing Medical Knowledge’

More announcements

What's new on this site

Library Home

Library Search

Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909