Exp Toxicol Pathol. 2008 Aug;60(4-5):323-7. Epub 2008 May 29.

Predictivity of animal studies for human injection site reactions with parenteral drug products.

Source

Amgen, Inc., Department of Comparative Biology and Safety Sciences, Thousand Oaks, CA 91320, USA. jengelha@amgen.com

Abstract

The value and predictive power of nonclinical studies for potential effects of investigational medicinal products in humans is often debated. The subject of general predictivity of animal toxicity studies has been addressed on several occasions, with one of the most recent efforts being conducted by an ILSI Task Group [Olson H, et al. Concordance of the toxicity of pharmaceuticals in humans and animals. Regul Toxicol Pharmacol 2000; 32: 56-67]. This review provides a summary of the evaluation of cutaneous toxicity, its histopathological assessment, and experience of the biopharmaceutical industry with respect to injection site reactions with parenteral drug products with a pragmatic perspective on the predictivity of standard animal studies with respect to these responses in humans.

PMID:: 18513931; [PubMed - indexed for MEDLINE]

Publication Types, MeSH Terms

Publication Types

Review

MeSH Terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Labome Researcher Resource - ExactAntigen/Labome

Medical

Skin Conditions - MedlinePlus Health Information

Supplemental Content

Save items

Related citations in PubMed

Review Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate? [Regul Toxicol Pharmacol. 2008]
Review Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: is 6 months still appropriate?
Clarke J, Hurst C, Martin P, Vahle J, Ponce R, Mounho B, Heidel S, Andrews L, Reynolds T, Cavagnaro J. Regul Toxicol Pharmacol. 2008 Feb; 50(1):2-22. Epub 2007 Aug 24.
Final amended report on the safety assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in cosmetic products. [Int J Toxicol. 2008]
Final amended report on the safety assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in cosmetic products.
. Int J Toxicol. 2008; 27 Suppl 4:1-82.
Lessons learned from independent central review. [Eur J Cancer. 2009]
Lessons learned from independent central review.
Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, et al. Eur J Cancer. 2009 Jan; 45(2):268-74.
Cutaneous drug reactions. [Tex Med. 1970]
Cutaneous drug reactions.
Rees RB. Tex Med. 1970 Feb; 66(2):92-3.
Review Testing retinal toxicity of drugs in animal models using electrophysiological and morphological techniques. [Doc Ophthalmol. 2009]
Review Testing retinal toxicity of drugs in animal models using electrophysiological and morphological techniques.
Perlman I. Doc Ophthalmol. 2009 Feb; 118(1):3-28. Epub 2008 Nov 9.

See reviews... See all...

Recent activity

Clear Turn Off Turn On

Predictivity of animal studies for human injection site reactions with parentera...
Predictivity of animal studies for human injection site reactions with parenteral drug products.
Exp Toxicol Pathol. 2008 Aug ;60(4-5):323-7. Epub 2008 May 29 .

PubMed
Heightened mortality after the death of a spouse: marriage protection or marriag...
Heightened mortality after the death of a spouse: marriage protection or marriage selection?
J Health Econ. 2008 Sep ;27(5):1326-42. Epub 2008 Apr 11 .

PubMed
HGPS and related premature aging disorders: from genomic identification to the f...
HGPS and related premature aging disorders: from genomic identification to the first therapeutic approaches.
Mech Ageing Dev. 2008 Jul-Aug ;129(7-8):449-59. Epub 2008 Apr 12 .

PubMed
Octacosanol isolated from Tinospora cordifolia downregulates VEGF gene expressio...
Octacosanol isolated from Tinospora cordifolia downregulates VEGF gene expression by inhibiting nuclear translocation of NF-<kappa>B and its DNA binding activity.
Eur J Pharmacol. 2008 Jul 7 ;588(2-3):141-50. Epub 2008 Apr 15 .

PubMed
Congenital joint dislocations caused by carbohydrate sulfotransferase 3 deficien...
Congenital joint dislocations caused by carbohydrate sulfotransferase 3 deficiency in recessive Larsen syndrome and humero-spinal dysostosis.
Am J Hum Genet. 2008 Jun ;82(6):1368-74.

PubMed

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

PubMed

Result Filters

Display Settings:

Send to: