Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

Table A.1.1: Values Used in the Calculations in this Document Rat body weight 425 g Mouse respiratory volume

43 L/day

Pregnant rat body weight

330 g

Rabbit respiratory volume Guinea pig respiratory volume Human respiratory volume Dog respiratory volume Monkey respiratory volume Mouse water consumption

1440 L/day 430 L/day 28,800 L/day

Mouse body weight

28 g 30 g

Pregnant

mouse

body

weight

Guinea pig body weight

500 g 2.5 kg

9,000 L/day 1,150 L/day

Rhesus monkey body weight

Rabbit body weight (pregnant or not)

4 kg

5 mL/day

Beagle dog body weight Rat respiratory volume

11.5 kg

Rat water consumption

30 mL/day

290 L/day Rat food consumption

30 g/day

References

1. United States Pharmacopeial Convention, Pharmacopeial Forum, Nov-Dec 1989.

2. IPCS. Assessing Human Health Risks of Chemicals: Derivation of Guidance Values for Health-based Exposure Limits, Environmental Health Criteria 170. International Programme on Chemical Safety. World Health Organization, Geneva. 1994. 3. US FDA, Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook 2000), available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInform ation/IngredientsAdditivesGRASPackaging/ucm2006826.htm. 4. Tvermoes BE, Unice KM, Paustenbach DJ, Finley BL, Otani JM, Galbraith DA. Effects and blood concentrations of cobalt after ingestion of 1 mg/d by human volunteers for 90 d. Am J Clin Nutr 2014;99:632-46.

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