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High
Carcinogenicity and General Toxicology
Reproductive and Developmental Toxicology*
Safety Pharmacology
High
Medium
Low
Safety Pharmacology
Respiratory Safety Pharm.
Cardiovascular Safety Pharm.
CNS Safety Pharm.
Renal/Urinary System
Autonomic Nervous System
Gastrointestinal System
Pharmacodynamic Drug Int.
Other studies
0
2
4
6
8
10 12 14
Priority (# responses per priority level)
Pharmacokinetics
Medium
Pharmacokinetics (PK)
Metabolism
PK Drug Interactions
Distribution
Absorption
Analytical Method/Valid. Report
Excretion
Other Pharmacokinetic Studies
High
Medium
Low
0
2
4
6
8
10 12 14
Priority (# responses per priority level)
Genetic Toxicology
Genotoxicity (in vivo)
Genotoxicity (in vitro)
Bacterial Reverse Mutation Assay (Ames)
Mammalian Cell Micronucleus Test
In Vivo Comet Assay
Mammalian Chromosome Aber. Test
Mamm. Erythrocyte Micronucleus Test
E. coli Reverse Mutation Assay
Mamm. Bone Marrow Chrom. Aber. Test
Mammalian Cell Gene Mutation Test
Sister Chrom. Exchange Assay in Mamm.
Tg. Rodent Som. & Germ Cell Gen Mut
Liver Unsched. DNA Synthesis
Pharmacology
Low
Pharmacology Studies
High
Medium
Low
0
2
4
6
8
10 12 14
Priority (# responses per priority level)
High
Medium
Low
Primary Pharmacodynamics
Secondary
Pharmacodynamics
0
2
4
6
8
10 12 14
Priority (# responses per priority level)
Figure 2A. Priorities for Nonclinical Study Types. Individual study types were rated as high,
medium, or low priority by survey respondents. Red Font indicates study groups that have
been standardized. Blue font denotes study types that are currently being standardized.
Asterisk (*) indicates that all study types within the Reproductive and Developmental
Toxicology were of a similar high priority based on survey results.