Table 5.

Relevant fields to document for an in vivo assay: example in vivo micronucleus

Compound identifier:	CASRN: 918639–08-4; Bosutinib
Compound purity:	99.49%
Compound solubility:	Not reported
Study call:	Negative
Title:	SKI-606: Single dose oral (gavage) bone marrow micronucleus study in male mice
Reference:	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341Orig1s000PharmR.pdf#page=151
Study type:	In vivo clastogenicity assay in rodent (micronucleus assay)
Source:	FDA CDER
Species (Number of subjects):	CD mouse (N=6)
Target cell/organ:	Bone marrow
Sex:	Male
TK parameters	Dose 2000 mg/kg, Cmax = 9811 ± 3998 ng/mL, tmax = 2.0 hr, AUC0–24 = 172495 ± 26050 ng*hr/mL
No observed adverse event level:	2000 µg/kg (from single dose toxicology study) (unit as stated in original report); it is assumed that this is an error and the correct level is 2000 mg/kg
Dose summary:	0, 500, 1000, and 2000 mg/kg as 10 ml/kg, single oral dose
Number of days of treatment:	1
Timepoints for tissue harvesting:	24h; 48h
Controls used:	Positive control: Cyclophosphamide (50 mg/kg)
Current guideline compliance	Yes (OECD 474)
Study Report:	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341Orig1s000PharmR.pdf
GLP compliance:	Yes
Year conducted	2003
Klimisch score:	1
Rationale for reliability incl. deficiencies: