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What is IMTC?
IMTC combines industry and academia experience in teaching
microsurgical and experimental techniques including telemetry.
Company Profile
The board is formed
by:
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Prof. Dr. René Remie, Scientific Director |
Prof. dr. Remie is the author and editor of "Manual of Microsurgery on the Laboratory Rat". He studied Pharmacy at the University of Groningen. In 1983 he specialized in phamacology and did his PhD on the presynaptic modulation of noradrenergic neurotransmission in the portal vein of the freely moving rat. In 1991 he specialized in Laboratory Animal Science. He is the Laboratory Animal Scientist of Solvay Pharmaceuticals. Since 1997 he holds a chair on Microsurgery and Experimental Technique in Laboratory Animals at the Groningen Centre for Drug Research, Department of Bio-Monitoring and Sensoring, University of Groningen, The Netherlands.
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Dr. Klaas Kramer, Technical Director |
Dr. Kramer is a specialist in radio-telemetry techniques. He did his thesis on the application and evaluation of radio-telemetry in small laboratory animals, at the Department of Laboratory Animal Science, Veterinary Faculty, Utrecht University, The Netherlands. He is employed a co-worker in Laboratoy Animal Science at the Free University of Amsterdam and part-time scientist at the Department of Laboratory Animal Science, Veterinary Faculty, University of Utrecht, The Netherlands.
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Besides the own expertise, MD has access to the outside know-how from universities and industry |
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IMTC works with very experienced instructors in microsurgery, experimental techniques and telemetry |
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IMTC is supported by an Advisory Board, existing of well-known experts on i.e. surgery, microsurgery, toxicology and animal welfare. |
When did it start
IMTC was founded in 2001 with the aim to
fill the gap created by the guidelines of the International Conference on
Harmonization on safety pharmacology issues. The ICH guideline on safety
pharmacology (ICHS7A) was recommended for adoption by regulatory bodies in the
European Union, United States and Japan in November 2000. In Europe and Japan
the guideline came into effect in June 2001 followed by the United States in
August 2001. The guideline calls for tests on the effects of compounds on vital
functions of the human body, such as the cardiovascular, respiratory and central
nervous system before first administration to man. The data provide specific
information on the safety profile of a new potential therapeutic agent and are
used by clinicians designing clinical studies and by regulatory agencies in
their assessment of the safety of a new product.
Test systems
The use of In Vivo and In Vitro Studies is
described in paragraph 2.3.2.
"In conducting in vivo studies, it is preferable to use unanaesthetized animals. Data from unrestrained animals that may be chronically instrumented for telemetry, other suitable instrumentation methods for conscious animals, or animals conditioned to the laboratory environment are preferable to data from restrained or unconditioned animals. In the use of unanaesthetized animals, the avoidance of discomfort or pain is a foremost consideration."
This makes it the first international guidelines to explicitly request unanaesthetized, chronically instrumented animals models be used in pharmaceutical development.
Implications for pharmaceutical industry
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Scientists need to be trained/certified to conduct procedures |
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Study Directors/Monitors need to be trained to develop protocols & supervise procedures |
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Education of animal welfare committees, staff, and the public |
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Technical aspects such as: aseptic procedures, anaesthesia, analgesia, etc. |
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Animal welfare develops to an important issue |