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
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