Abaloparatide is a bone density conservation agent indicated for the treatment of osteoporosis in postmenopausal women at high risk for vertebral and/or non-vertebral fractures. It is a PTH1 receptor (PTH1R) agonist that activates the cAMP signaling pathway in target cells. In rats and monkeys, abaloparatide had an anabolic effect on bone, demonstrated by increases in bone mineral density (BMD) and bone mineral content (BMC) that correlated with increases in bone strength at vertebral and/or nonvertebral sites.

Why do you need a Abaloparatide monograph?

Superior Toxicology and Wellness’s monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs)

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA’s Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

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