Study

Concordance of the Toxicity of Pharmaceuticals in Humans and in Animals

2000 · other · peer reviewed: yes · record 11029269 · PubMed

6 findings kept from this study. Each is one sentence comparing an animal with a human, extracted from the full text, checked against the located page, and adjudicated against the review's definition of an animal-versus-human comparison.

The true positive human toxicity concordance rate for one or more preclinical animal model species was 70% for 221 human toxicity events.

Concordant · level B · no species named · cross-cutting toxicology · 70 percent · n /221

“Overall, the true positive concordance rate (sensitivity) was 70% for one or more preclinical animal model species (either in safety pharmacology or in safety toxicology) showing target organ toxicity in the same organ system as the HT (Fig. 3).”
page 4

The true positive human toxicity concordance rate for nonrodent species was 63% for human toxicity events.

Concordant · level B · no species named · cross-cutting toxicology · 43–63 percent · n /221

“Concordance was seen in 63% of nonrodent studies (primarily the dog) and 43% of rodent studies (primarily the rat).”
page 5

The true positive human toxicity concordance rate for hematological human toxicities was 91% with animal findings.

Concordant · level B · no species named · hematology · 91 percent

“Hematologic HTs correlated in high degree (91%) with animal findings, with rodents and nonrodents both being responsive.”
page 8

Gastrointestinal human toxicities overall correlated well (85%) with animal findings, especially in nonrodents.

Concordant · level B · no species named · liver/GI · 85 percent

“Gastrointestinal HTs overall correlated well (85%) with animal findings, especially in nonrodents.”
page 8

Cardiovascular human toxicities had a high rate of concordance (80%) with animal studies.

Concordant · level B · no species named · cardiovascular · 80 percent

“Cardiovascular HTs had a high rate of concordance (80%) with animal studies.”
page 8

The true positive human toxicity concordance rate for cutaneous human toxicities was the least among all organ systems.

Discordant · level B · no species named · dermatology

“The best concordance was for hematological, gastrointestinal, and cardiovascular toxicities and the least was for cutaneous toxicity.”
page 5