35. Research in lab animal & comparative medicine

Health policy

evidence base medicine, epidemiology

LAM clinical practice

Drug safety testing for animal use, pre-clinical animal trials, comparative effectiveness

Comparative Medicine

animal model development, drug safety testing for human use

Basic Research

molecular pathogenesis & comparative anatomy/physiology, Disease discovery

What is Good Laboratory Practices (GLP)?

Widely applied standard for quality assurance in lab work involving animals

Highly formalized and structured mechanism to guide the conduct of drug approval and chemical safety studies for approval by the FDA

Use of SOP and documentation of all study activities and any changes in study plan essential to success

This is the NIH grant supported by almost all NIH Institutes and Centers (IC) and no specific dollar limit unless stated; Supports a discrete, specified, circumscribed research project, awards usually for 3-5 years;

RO1

Limited funding for pilot studies, development of new research technology, etc. Only 2 years of funding; Direct costs up to $50,000/year

RO3

awards are for post-doc study at an eligible institution

F32

awards can be for pre- or post-doctoral training programs

T32

Mentored Research Scientist Development Award

K01

Independent Scientist Award

K02

Mid-career Investigator Award

K26

Senior Scientist Research Award

K05

Research Program Project Grants provide support for integrated multi-project, multi-investigator research projects

P01

Center Core Grants provide support for shared resources and facilities for multidisciplinary approach to a joint research effort by multiple investigators

P30

National Primate Research Center base grants

P51

Procedures or measures taken to eliminate or minimize pain or distress in the animal(s) or enhance animal well-being. Examples include use of analgesics, telemetry, environmental enrichment, and imaging.

Refinement

Procedures or measures taken to reduce the number of animals used. Examples include use of historical controls, in vitro screening, and proper use of statistics.

Reduction

Procedures or measures taken to reduce the number of animals used. Examples include use of non-animal models and use of less sentient species.

Replacement

What is NTP Interagency Center for the Evaluation of Alternative Toxicological Methods? Who made it? What does it do?

• ICCVAM

• A) evaluates new test method submissions and nominations for their adherence to the ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods

• B) assesses the completeness of background review documents submitted for ICCVAM evaluation, 

• C) determines whether and to what extent new, revised, and alternative test methods proposed for ICCVAM evaluation are applicable to regulatory safety testing

• D) assembles information about current best practices for the humane care and use of animals in toxicological research and testing.

• Species: Mouse

• Purpose: To identify substances that could cause allergic contact dermatitis in humans

• Replaces Guinea Pigs methods

• Advantages:

  • Less time to perform

  • Provides dose-response information

  • Typically eliminates pain and distress

Murine local lymph node assay

• Replaces live animal testing of corrosives and irritants

• Draize test in rabbits. This test was developed to determine ocular toxicity caused by products and chemicals. Ocular toxicity tests represent one of the four most commonly conducted product safety

• 4 tests - what are they?

• The isolated rabbit eye (IRE) test method 

• The isolated chicken eye (ICE) test method 

• The bovine corneal opacity and permeability (BCOP) test method 

• The hen's egg test - chorioallantoic membrane (HET-CAM) test method

• Screens for the presence of endotoxin

• Species: Limulus polyphemus

  • Common name?

• Replaces: Rabbit pyrogen testing

 Amebocyte Lysate (LAL) Assay