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Important Step Taken To Reduce Animals Used In Specific Safety Test For New Medicines
Thousands of rodents per year are no longer being used in a particular test needed to develop new
medicines. This outcome follows an extensive review by 18 pharmaceutical companies and the
NC3Rs(1) with the support of EFPIA(2). The review, published in Regulatory Toxicology and
Pharmacology(3), shows that this particular toxicity test, which can cause substantial effects to
animals, is now redundant. In fact, the review has already led to more than a 70% reduction in
animal use in acute toxicity tests by the companies involved, and there clearly is even greater
potential for reducing animal use for this test worldwide.
Toxicity testing of new medicines for humans and animals accounts for 4% of all animal use in
Europe, which means just under half a million rats and mice are used for this purpose each year(4).
The estimated reduction of 15,000 in animal use following this review equates to around 3.5% of
the rats and mice used in testing new human or veterinary medicines or dentistry products.
Given recent changes in the process for developing medicines, the review's authors questioned the
need for a particular animal test that has been required in the safety testing of new medicines. The
evidence they gathered showed that the information obtained had little or no value in assessing the
risk to humans. The review focussed on the single dose acute toxicity test, which is usually
conducted prior to the first clinical trial in humans. It is traditionally required to identify the dose of a
medicine that causes major toxic effects.
The leader of the review, Dr Sally Robinson AstraZeneca, said: "Appropriate safety testing with
animals is a worldwide regulatory requirement, providing protection to the public and providing
doctors with important information on how to administer new medicines. Before new medicines are
administered to humans, their safety is evaluated by screening for potentially harmful effects. This
screening is mostly done using animals since these currently provide the best prediction of what
might happen in people.
"In light of our desire to replace, refine and reduce animal use wherever possible, we were keen to
examine whether there was a better way to conduct this type of test. We continuously shared and
reviewed information between 2003 and 2007, which provided the evidence to reduce animal use
by demonstrating that this acute toxicity test is no longer needed before a new medicine is tested in
humans. While we recognize that this reduction represents a small proportion of the total, it is an
important step in the right direction."
Dr Kathryn Chapman, co-ordinator of the project, NC3Rs said: "The next step has to be changing
the regulations that require this test to be carried out and the NC3Rs and the companies are
working hard to achieve this with worldwide regulatory bodies.
"This novel approach shows that significant progress can be made by going back to first principles
and examining the need for a particular test, rather than trying to replace the test with non-animal
methods. It also highlights that impressive results can be achieved when companies share
appropriate data in a focused way and the NC3Rs has adopted a similar approach in other areas of
animal use."
Brian Ager, Director General of EFPIA, said: "These findings have been considered as part of a
revision of the international guidelines on toxicity testing which is currently underway, and the
companies involved have already achieved significant reductions in animal use. We hope that the
regulators, who have been involved throughout the project, will accept the evidence and no longer
require this test prior to testing in man."
Notes:
1. NC3Rs is the National Centre for the Replacement, Refinement and Reduction of Animals in
Research - an independent, scientific organisation which finds innovative solutions to:
- Replace animals in research with non-animal alternatives
- Reduce the number of animals used in experiments
- Refine scientific procedures and animal husbandry to minimise suffering
The Centre funds high-quality research, organises workshops and symposia to disseminate and
advance the 3Rs, and develops information resources and guidelines. It is an independent
organisation, set up by the Government in 2004, and reporting to the Science Minister and
stakeholders through the publication of an annual report. More information can be found here:
http://www.nc3rs.org.uk
2. EFPIA is the European Federation of Pharmaceutical Industries and Associations and represents the
research-based pharmaceutical industry operating in Europe. Through its direct membership of 32
national pharmaceutical industry associations and 44 leading pharmaceutical companies, EFPIA is
the voice on the European scene of about 2100 companies committed to researching, developing and
bringing to patients new medicines that improve health and quality of life around the world.
http://www.efpia.eu
3. The paper is entitled 'A European pharmaceutical company initiative challenging the regulatory
requirement for acute toxicity studies in pharmaceutical drug development' and is published online
today. Regulatory Toxicology and Pharmacology can be found online
here.
4. Fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific
Purposes in the Member States of the European Union {COM (2007) 675 final}
http://www.efpia.eu
Pas important luate pentru a reduce animalelor utilizate în siguranþã specifice test pentru noi medicamente - Important Step Taken To Reduce Animals Used In Specific Safety Test For New Medicines - articole medicale engleza - startsanatate