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Human and Animal Testing: What’s Appropriate. HUMAN AND ANIMAL TESTING; WHAT’S APPROPRIATE? JOHN DOULL. As toxicologists we share responsibility for providing answers to the public for safety questions; Is it safe? & Will it hurt me? To provide answers, we need the “right” information:
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HUMAN AND ANIMAL TESTING; WHAT’S APPROPRIATE? JOHN DOULL • As toxicologists we share responsibility for providing answers to the public for safety questions; Is it safe? & Will it hurt me? • To provide answers, we need the “right” information: • Right chemical, right exposure scenario, right subject. • Chemical/agent identity: (wrong salt, racemate); purity (mixture); surrogate with similar physical, chemical and/or biological properties etc. • Tool: SAR
HUMAN AND ANIMAL TESTING; WHAT’S APPROPRIATE? JOHN DOULL • Exposure: wrong dose/duration, wrong route etc. • Tools: interpolation, kinetics/Haber, extrapolation. • Subject or target: Population/individual; susceptibility (sex, age, race, disease, environment etc.). • Tool: surrogate species, WOE.
TYPICAL COSTS OF DESCRIPTIVE TOXICITY TESTSCasarett & Doull, Chapter 2, 6th Ed.
TYPICAL COSTS OF DESCRIPTIVE TOXICITY TESTSCasarett & Doull, Chapter 2, 6th Ed.
HOW RELIABLE ARE ANIMAL TESTS? • Quantitative: species vary in their susceptibility: PPAR • Qualitative: some species have unique ability: Alpha-2-glob • Protocols with inadequate power: Vioxx • Protocols inadequate: headache, depression, anxiety Alternatives Alan Goldberg, CAAT at John’s Hopkins, Celebrating 25 years in 2006, Hits?
PROPOSED TIMEFRAME FOR FULL REPLACEMENT OF ANIMAL TESTS SCCNFP, 2004 Annual European Meeting Toxicology Forum, Brussels, 091105