properties of drugs: in vivo studies

directive EU2010/63

• governs the protection of animals for scientific purpose

• enforces the 3R principle

• banning use of great apes and wild caught animals

Name and briefly outline each of the 3Rs of animal research. (6 marks)

• reduction - using the smallest number of animals possible, using species with a larger little size

• replacement - do not use an animal if there is an alternative, absolute eg molecular modelling, relative eg cell lines, tissue samples

• refinement - make lives of research animals as painless and stress free as possible, eg use of anaesthetics and analgesia

How often must project licence holders report the number of regulated procedures carried out under their licence? (1 mark)

every year

Identify two named officials required for UK animal licences and briefly explain their role. (4 marks)

• named veterinary surgeon - controls health, welfare and treatment of lab animals

• named training and compliance officer - ensure all staff are educated, trained and supervised until competenent

Identify 4 named officials required for UK animal licences

• Named veterinary surgeon (NVS)

• Named animal care and welfare officer (NACWO)

• An individual responsible for ensuring all staff are adequately educated, trained, and supervised until competent (NTCO)

• Individual responsible for all compliance (NCO)

animal scientific procedures act (ASPA)

• controls any experimental or other scientific procedure applied to a protected animal

  • any living vertebrates

  • all cephalopods

  • immature forms

licnecnes required for animal scientific procedures act

• establishment licence (where)

• project licence for research (what)

• personal licence for individuals working on project (who)

human office inspectors

• qualified individuals

• right of entry to ensure compliance with ASPA

• announced and unannounced visits

what is establishment licence required for

• breeding

• supply

• scientfiic procedures

permissible purposes for project licence

• basic research

• avoidance, prevention, diagnosis or treatment of disease

• assessment, detection, regulation or modification of physiological conditions

• improvement of welfare of animals

• research for preservation of species

• forensic inquiries

personal licence

• Requires accredited training and competency qualifications

• Permits procedures to be carried on specified protected species

ethical review of project licence determines

• whether research is justified

• whether similar work is being done elsewhere

• whetehr the 3Rs are being followed

what does AWERB stand for

• animal welfare and ethical review body

what is the animal welfare and ethical review body?

• local panel which provides independent welfare and ethical advice

• support regarding ethics and welfare

• promotes 3R implementation

when will a licence be granted

• cannot be achieved through another method without animals

• use of min number of animals with appropriate experimental design

• use species with lowest degree of neurophysiological sensitivity

• cause least pain, suffering and distress

• demonstrates there is no alternative to using animal

• benefit to society outweighs cost to animal

what are the 3Rs?

• ethical framework dor conducting scientific experiments using animals humanely

• reduction

• refinement

• replacement

replacement

• do not use animal if there is an alternative

reduction

• use the smallest number of animals possible

refinement

• do everything possible to make the lives of research animals as painless, pleasant and stress-free as possible

absolute replacements thay can be implemented

• computer modelling, in vitro, human volunteers

• ames test - test for mutagenicity

relative replacements

• animal cell lines

• cells, tissues and organs

• invertebrates

• early gestation of mammals, birds and reptiles

examples of reduction of animal testing

1.Improved experimental design and statistical analysis

2.Advances in imaging techniques

3.Sharing of data and resources

4.Species selection

refinement examples

• non invastive techniques

• appropriate analgesia and anaesthesia

• training animals to co-operate with certain procedures so less stressed

• ensuring accomodation meets animals needs

• environmental enrichment to improve living conditions for research animals

how is reporting conducted for animal testing

• details of number of regulated processes - animals, effect of painor stress, scientific or educational

• home office publishes stats on number of species

how have animal procedures changed since the introduction of ASPA

• number of procedures initially decreased

• due to reduction in use of rodents, rabbits and birds in research

• recent increase is due to advances in transgenic technologies

what are alternative methods to in vivo studies-

• molecular biology

• computer modelling

• in vitro

advantages of using in vivo over in vitro, molecular biology and computer modelling

1.Determine effects in the whole body

2.Determine long-term effects

3.Determine pharmacokinetics

4.Reveal the unexpected

5.Set the clinical dose range

6.Assess safety and toxicology

examples of drugs/compounds which needed in vivo testing

• clonidine - antihypertensive effects only seen in vivo

• fluconazole - more modest in vitro action than in vivo