TERIPARATIDE Lilly Research Laboratories

7/31/01


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Table of Contents

TERIPARATIDE Lilly Research Laboratories

TERIPARATIDE Lilly Research Laboratories

Main Preclinical Issue

Carcinogenicity Studies

Carcinogenicity Study with Teriparatide

Teriparatide Causes Bone Neoplasms in the Rat Percent of animals with tumors

Systemic Exposure to Teriparatide

Incidence of Osteosarcoma by Multiple of Human AUC

Sites of Osteosarcoma Order of frequency

Male Rats with Osteosarcoma Time of Death

Female Rats with Osteosarcoma Time of Death

Control Incidence of Osteosarcoma in F344 Rats

Relative Risk of Osteosarcoma in Teriparatide-Treated Rats

Effect of Teriparatide on Bone Mass (Female Rat)

Conclusions Results of 2-year rat study

Risk Assessment Hormonal Carcinogenesis

Teriparatide-Induced Rat Bone Tumors

Clinical Relevance of Rat Bone Tumor Finding

Further Considerations on Clinical Relevance of Tumor Finding

Validity of Rat Model

Validity of Rat Model

Follow-up Animal Studies

Conclusions

Author: Jeanine Vinson